Suture passing instrumentation and methods of use thereof

ABSTRACT

The instant disclosure is directed to methods and devices for passing suture bi-directionally using a hybrid approach. Embodiments of a method described herein include steps of advancing a suture at least partially through tissue; and retrieving the suture; wherein one of the steps of advancing and retrieving comprises manipulating the suture directly, and wherein the other step of advancing and retrieving comprises manipulating a suture trap to which the suture is coupled. Embodiments of a device that may be used to practice the method embodiments include a bi-directional suture passer having a proximal portion for holding a portion of a suture therein; a distal tip coupled to the proximal portion and defining a tissue receiving gap there-between; a reciprocally moveable suture passing member housed within the proximal portion for translating the suture portion between the proximal portion and the distal tip; and a suture trap operable to be detachably coupled to the distal tip for capturing the suture passed by the suture passing member.

TECHNICAL FIELD

The disclosure relates to a method for passing a suture through tissue.More specifically, the disclosure relates to a method for passing suturethrough tissue bi-directionally.

SUMMARY

The instant disclosure is directed to methods and devices for passingsuture bi-directionally using a hybrid approach. Such an approachinvolves translating a suture strand in one direction directly, that iswithout requiring the suture to be coupled to a shuttle or ferrule,while translation of the suture in the other direction is accomplishedby using a suture trap to capture the suture and translating the suturetrap along with the suture.

A hybrid method such as is described hereinbelow provides severalheretofore unknown and unrecognized advantages. These include, but arenot limited to, the following: In designs utilizing a shuttle or ferruleto carry the suture both to and from the distal tip, the first pass ofthe shuttle to the tip requires the shuttle to be coupled to the distaltip in some manner. This coupling can, in certain instances, becompromised by tissues or bodily fluids entering the device, or damageby the user, whereby the security and integrity of the trap is lessened.Furthermore, unintended severing of the suture during the first passresults in a free-floating shuttle or ferrule within the patient's body,whereas a hybrid approach, whereby one pass of suture is done withoutrequiring a shuttle or ferrule, leaves only a comparativelyinsignificant section of suture for the same failure mode. Furthermore,in designs passing suture in both directions without utilizing a shuttleor ferrule, the ability to securely grasp a suture once it has enteredthe body is difficult to implement in a consistent and reproduciblemanner. A hybrid approach, whereby suture is captured by a suture trapprior to being translated in a second pass, provides an advantage sinceretrieving a suture trap is significantly more achievable.

Employing a suture trap, that is a component configured to capture orretain a suture once it is passed through the material to be sutured,provides a unique and unanticipated advantage over shuttles and ferrulesto which the suture is pre-attached, as it facilitates certain methodsutilizing a hybrid approach as discussed hereinabelow.

In one broad aspect, embodiments of a method described herein includesteps of advancing a suture at least partially through tissue; andretrieving the suture; wherein one of the steps of advancing andretrieving comprises manipulating the suture directly, and wherein theother step of advancing and retrieving comprises manipulating a suturetrap to which the suture is coupled.

In another broad aspect, embodiments of a device that may be used topractice the method embodiments include a bi-directional suture passerhaving a proximal portion for holding a portion of a suture therein; adistal tip coupled to the proximal portion and defining a tissuereceiving gap there-between; a reciprocally moveable suture passingmember housed within the proximal portion for translating the sutureportion between the proximal portion and the distal tip; and a suturetrap operable to be detachably coupled to the distal tip for capturingthe suture passed by the suture passing member.

Various features of this aspect are described as well, including but notlimited to depth selection mechanisms, interlocking features forcoupling and de-coupling components and suture routing features tominimize risk of suture damage during a suture passing procedure.

In an additional broad aspect of the present invention, devices andmethods are disclosed for controlled deployment of a knot, such as apre-tied knot, from a device such as a medical instrument. Features ofthis aspect include a knot carrier or slider, a retaining element formaintaining tension on a portion of a suture strand as well as means forrouting suture for controlled knot deployment.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the invention may be readily understood, embodiments ofthe invention are illustrated by way of examples in the accompanyingdrawings, in which:

FIGS. 1a, 1b are an illustration of a device for practicing a method inaccordance with an embodiment of the present invention;

FIGS. 2a-2f illustrate steps of a method in accordance with anembodiment of the present invention;

FIGS. 3a-3d illustrate further steps of a method in accordance with anembodiment of the present invention;

FIGS. 3e-3h illustrate alternative embodiments of a device and method inaccordance with the present invention;

FIGS. 4a-4b illustrate steps of a method in accordance with anembodiment of the present invention;

FIGS. 4c-4g illustrate various components of a device in accordance withan embodiment of the present invention;

FIGS. 4h-4o illustrate a device in accordance with an alternateembodiment of the present invention;

FIG. 5a-5e illustrate steps of a method in accordance with an embodimentof the present invention;

FIGS. 6a-6h show a device and method in accordance with an embodiment ofthe present invention;

FIGS. 6i-6l illustrate a device and method in accordance with analternative embodiment of the present invention;

FIGS. 6m-6x illustrate a device and method in accordance with yetanother alternative embodiment of the present invention;

FIGS. 6m (i)-6 w(ii) illustrate a device and method in accordance withyet another alternative embodiment of the present invention;

FIGS. 7a-7e illustrate a suture holder and a stylet, in accordance withan embodiment of the present invention;

FIGS. 8a-8b illustrate steps of a method in accordance with anembodiment of the present invention;

FIGS. 9a-9i illustrate steps of a method in accordance with alternativeembodiments of the present invention;

FIGS. 10a-10f illustrate steps of a method in accordance with analternative embodiment of the present invention;

FIGS. 11a-11d illustrate steps of a method in accordance with analternate embodiment of the present invention.

FIGS. 12a-12f illustrate steps of a method in accordance with analternate embodiment of the present invention;

FIGS. 13a-13d illustrate steps of a method in accordance with analternate embodiment of the present invention;

FIGS. 13e-13g illustrate a suture holder in accordance with an alternateembodiment of the present invention;

FIGS. 14a-14f illustrate steps of a method in accordance with analternate embodiment of the present invention;

FIGS. 15(a)-(c) illustrate steps of a method in accordance with analternate embodiment of the present invention;

FIG. 16 illustrates a suture holder in accordance with an alternateembodiment of the present invention;

FIGS. 17a-17c illustrate steps of a method in accordance with analternate embodiment of the present invention;

FIGS. 18a-18c illustrate steps of a method in accordance with analternate embodiment of the present invention;

FIGS. 19a-19g illustrate a device and method in accordance with analternate embodiment of the present invention;

FIGS. 20a-20e illustrate a device and method in accordance with anotheralternate embodiment of the present invention;

FIGS. 21a-21e illustrate a device and method in accordance with anembodiment of the present invention;

FIGS. 22a and 22c-22k illustrate a device and method in accordance withembodiments of the present invention;

FIGS. 23a-23e illustrate a device and method in accordance with anotherembodiment of the present invention;

FIG. 24 illustrates a device and method in accordance with an alternateembodiment of the present invention;

FIGS. 25a-25e illustrate a device and method in accordance with anotherembodiment of the present invention;

FIGS. 26a-26b illustrate a device and method in accordance with anotherembodiment of the present invention;

FIGS. 27a-27d illustrate a device and method in accordance with stillanother embodiment of the present invention;

FIGS. 28a-28h illustrate a device and method in accordance with stillanother embodiment of the present invention; and

FIGS. 29a-29e illustrate a device and method in accordance with anotherembodiment of the present invention.

DETAILED DESCRIPTION

According to one broad aspect embodiment of the present invention thereis provided a method for treating a defect within a region of tissue.The method is effected by positioning a suture holder on a distal sideof a tissue and passing a suture through the tissue from the proximalside and coupling the suture to the suture holder. The suture holder isthen retrieved through the tissue towards the proximal side of thetissue.

With specific reference now to the drawings in detail, it is stressedthat the particulars shown are by way of example and for purposes ofillustrative discussion of certain embodiments of the present inventiononly. Before explaining at least one embodiment of the invention indetail, it is to be understood that the invention is not limited in itsapplication to the details of construction and the arrangement of thecomponents set forth in the following description or illustrated in thedrawings. The invention is capable of other embodiments or of beingpracticed or carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein is for the purposeof description and should not be regarded as limiting.

Overall Device Structure

Suture Passing Device

FIGS. 1a-b illustrate one aspect of a device for treating a defect in atissue which is referred to herein as device 100. Device 100 may beconfigured for accessing tissue (e.g. disc annulus fibrosus tissue)having a defect and delivering an element such as a suture 240 throughthe tissue to treat the defect. In some embodiments, the suture may beresorbable. Device 100 includes a proximal portion 14 (also referred toherein as “device proximal portion 14”) and a distal portion 13 having aneck portion 15 and a distal tip 12 (also referred to herein as “devicedistal tip 12”). Distal tip 12 is longitudinally spaced apart fromproximal portion 14 and is coupled thereto via the longitudinallyextending neck portion 15. According to one embodiment, distal tip 12 iscoupled to a shaft 16 of the proximal portion 14 defining a tissuereceiving gap 10 therebetween. Device 100 can be positioned such thatdistal tip 12 is positioned on a distal side of the tissue being treatedand proximal portion 14 is positioned on a proximal side of the tissue.

Device 100 may comprise an actuator, actuating member or actuatingmechanism (such as a trigger 218 shown in FIG. 1a ) for advancing thevarious components within the device such as needle 116 and stylet 319,as described herein below, from the proximal portion 14 towards distaltip 12 of device 100. The trigger 218 may be used for advancing bothneedle 116 and stylet 319 in a direction along the longitudinal axis ofdevice 100. As trigger 218 is actuated, both needle 116 and stylet 319translate longitudinally from the proximal portion 14 towards distal tip12. The needle 116 and stylet 319 may be configured to retractproximally back towards proximal portion 14 of device 100 when trigger118 is released. As described further hereinbelow, the actuating memberallows for at least two degrees of manipulation for advancing variouscomponents of the device 100 by differing amounts.

Structures internal to the handle 100 are presently described withreference to FIGS. 1.a and 1 b. As shown in FIG. 1a , the handle 100comprises a handle body 14 that defines an inner chamber 140 (withinwhich a stylet hub 430 and a needle hub 130 are located) where thestylet hub 430 is coupled to the stylet 319 and the needle hub 130 iscoupled to the needle 116. The trigger 218 has a geared portion 220 thatco-operatively engages with a gear rack 434 of the stylet hub 430 toallow the stylet hub 430 and the needle hub coupled thereto to slidewithin the chamber 140 defined by the handle of device 100.

Interlock or Needle Release Button

In some embodiments, a means for decoupling/coupling two coaxial membersduring translation, such as (i) a suture passing or suture holderretrieving member (e.g. stylet 319), and (ii) a tissue puncturing member(e.g. needle 116), is disclosed. The means for decoupling/couplingallows one member to travel further than the other, whereas translationof both members is affected by a single trigger. As shown in FIG. 1a ,needle 116 and stylet 319 are coupled using a needle release button 600which allows the needle hub 130 to co-operatively engage with the stylethub 430 allowing the needle 116 and stylet 319 combination to beadvanced together.

Depth Selection Mechanism

In some embodiments, an element for controlling the translation distanceof a suture passing element/suture holder retrieving element such as astylet 319 is provided, such that the translation distance of the stylet319 at a first actuation of a trigger is different than the translationdistance of the stylet 319 at a second actuation of the trigger. Inorder to allow for varying the distance to which a stylet 319 isadvanced when the trigger 218 is actuated, certain embodiments of thepresent invention provide a depth selection mechanism (depth selector)500, as shown in FIG. 1a . Thus, the depth selector 500 allows variousdegrees of advancement of the stylet 319 in terms of how far it can betranslated relative to the needle 116. In some embodiments the depthselector 500 fits into the stylet hub 430, as shown.

Tissue Puncturing Member

In some embodiments, a tissue puncturing member, such as a needle 116may be housed within the device proximal portion 14 may be used topuncture tissue to allow the suture passing member such as stylet 319 tobe passed through the tissue. The needle 116 may be hollow and maydefine a lumen therethrough for housing a Stylet 319 and suture 240therein. In one specific example, the needle 116 may be beveled at itsdistal end to allow engagement or interaction with the suture holder 316to allow suture to be passed through a channel formed therebetween. Insome embodiments, the suture passing member (e.g. stylet 319) may becoupled to the tissue puncturing member (e.g. a needle 116) for at leasta part of the procedure.

Suture Passing Member

Device 100 has a suture passing mechanism capable of passing an elementsuch as a suture 240 from proximal portion 14 to distal tip 12 (in orderto pass the suture 240 from the proximal side of the tissue to thedistal side of the tissue). Suture passing mechanism can include amoveable suture passing member, such as a stylet 319, which is housedwithin proximal portion 14. Stylet 319 is moveable between a proximalposition and first or second predetermined distal positions. The stylet319 is configured for passing suture knot 250 through tissue 200 andcoupling suture knot 250 to suture holder 316 attached to the distal tip12. This enables passing of suture 240 through tissue 200. Device 100further includes a mechanism for retrieving suture holder 316 fromdistal tip 12 such that suture holder 316 (and the suture coupledthereto) is passed from the distal side to the proximal side throughtissue 200. Such a mechanism can include a suture holder retrievingmember such as a stylet 319. Thus, stylet 319 is further configured forretrieving suture holder 316 (and thus the suture knot 250 coupledthereto) from the distal tip 12. Suture holder retrieving member islongitudinally translatable between proximal portion 14 and distal tip12 and is optionally capable of reciprocal movement. Thus, in someembodiments stylet 319 is capable of passing a portion of suture 240(which may include a knot 250), from proximal portion 14 to sutureholder 316 at distal tip 12 and for retrieving suture holder 316 fromdistal tip 12 to proximal portion 14.

Suture Portion

An element such as suture 240 is housed within proximal portion 14 ofdevice 100. According to one example, a portion of the suture 240 suchas a knot 250 is held within the device proximal portion 14 adjacent toa suture passing member such as stylet 319, so that it can be passedthrough tissue by the stylet 319 as it advances from the device proximalportion 14 to the distal tip 12. In other embodiments, the elementpassed by the suture passing member may be an anchor which may beoperatively coupled to the suture passing member.

Slotted Needle and Shaft

In some embodiments as show in FIG. 1b , the device 100 describedcomprises a slot 117 within the needle 116 and a similar slot 117′within the shaft to allow the suture 240 to be routed to secure thesuture in place. The suture 240 is guided through slot 117 to theexterior of the needle and exists through as similar slot formed withinthe shaft 16 as later shown in FIGS. 28a and 28b . The needle and shaftslots may be offset from one another. The knot 250 of the suture 240 isunable to pass through the slot within the needle, thus securing theknot 250 within the needle lumen.

Suture Holder/Suture Trap

Device 100 further includes a suture holder 316 that is removablyattached to distal tip 12. The suture holder 316 is capable of receivinga portion of a suture 240 such a as a knot 250 from the proximal portion14 of the device 100 from a suture passing member such as a stylet 319and retaining it at the distal tip 12.

In one specific example, as shown in FIG. 1a , suture holder 316 isremovably attached to the distal tip 12 of device 100 via a trapengagement feature such as wire 20 which interacts with a tip engagementfeature of the trap (such as a window, slot or aperture) for allowingthe suture holder 316 to be held within a receiving chamber 12B definedby the device distal tip 12. The wire 20 may be attached to a wire stop18 which may allow removal of wire to decouple the suture holder 316from the distal tip.

Detailed Device Structure

The structure of a device 100 is described in further detail hereinbelow with reference to FIGS. 2a -7 e.

Distal Tip

In embodiments described in FIGS. 2a-3d , the device comprises a distaltip 12. The distal tip 12 may comprise a chamber 12B (FIG. 3d ) forreceiving the suture holder 316. The chamber 12B may define a lumentherethrough and may be open at both of its longitudinally opposed ends.In one embodiment as additionally shown in FIGS. 1a-b the distal tip 12may taper towards its distal end to facilitate positioning oradvancement of the device 100 within a region of tissue. In someembodiments the device 100 includes a suture retaining element forretaining a portion of the suture 240 such as a suture knot 250 on adistal side of the tissue. In one embodiment, the suture retainingelement may be a component of the distal tip 12. In some embodiments, asshown in FIG. 2d , the suture retaining element can be, for example acomponent of the suture holder, e.g. a distal opening thereof, with thesuture holder being received within a the distal tip 12.

In one specific example, distal tip 12 of device 100 defines a receivingchamber 12B which holds suture holder 316 therein. As mentioned above,the suture holder 316 may be detachably coupled to the distal tip 12.Suture holder 316 comprises an engagement feature for detachablycoupling the suture holder 316 to the distal tip 12. In one specificexample, suture holder 316 is initially detachably coupled to the distaltip 12 within receiving chamber 12B using a wire 20 that is receivedwithin an opening or channel 320 of suture holder 316, as is furthershown in FIGS. 2a-2f and FIGS. 3a-3c . The wire 20 is threaded throughan opening or aperture in the distal tip 12 and into the receivingchamber 12B; it is received within the opening 320 of the suture holder316 and secures the suture holder 316 within the receiving chamber 12B.The wire 20 may be attached to a wire stop which, when actuated, allowswire 20 to be removed. As shown in FIG. 3d , the wire 20 may be at leastpartially removed or retracted such that wire 20 is no longer coupled tosuture holder 316, to allow disengagement of the suture holder 316 fromthe receiving chamber 12B of the distal tip 12. This enables retractionor retrieval of the suture holder 316 by the suture holder retrievingmember which in this example comprises the stylet 319.

Mechanism for Enabling Differential Advancement of Needle and Stylet

Various embodiments or implementations of an engagement and releasemechanism are provided to allow the stylet 319 to selectively engagewith, and disengage from, the needle 116. In one example, acoupling/decoupling mechanism is provided (i) to couple the stylet hub430 to the needle hub 130 in order to move the needle 116 and the stylet319 together as an assembly, and (ii) to later decouple the needle hub130 from the stylet hub 430 to allow the stylet 319 to advance on itsown.

Manual Interlock or Needle Release Button for Coupling and Decouplingthe Stylet and the Needle

The coupling/de-coupling mechanism may be in the form of a needlerelease button 600 as shown in FIGS. 4a-4g . In its initial position thebutton 600 has both the needle hub 130 and the stylet hub 430 coupled.The button can be depressed manually for decoupling the two hubs. Theneedle release button 600 may be a spring-loaded button where the springis biased away from the needle hub 130 in its first/initial position orthe nominal position 600A. In one example, the button 600 may beconnected to the needle hub 130 or may be a part of the needle hub 130.In its nominal position 600A, the button 600 provides an interferenceblock 601 which obstructs the path the stylet hub 430 (and thus thestylet hub proximal portion 432), obstructing/impeding the movement ofthe stylet 319, as is further illustrated in FIG. 4d . Morespecifically, first the needle release button 600 in position 600Acouples the needle hub 130 to the stylet hub 430 (which is driven byactuation of a trigger). By coupling the two hubs, the actuation of thetrigger drives both the stylet 319, and the needle 116 forward. Thisforward translation stops when the needle 116 hits the suture holder316. At this point, the interference block 601 of needle release button600 is obstructing/impeding the stylet hub 430.

When the button 600 is depressed (compressing the spring 603), thebutton 600 moves from its first position 600A to its second position600B as shown in FIGS. 4e and 4f . Depressing the button 600 removes theobstruction created by the interference block 601 and allows the stylethub 430, and thus the stylet hub proximal portion 432 to translaterelative to the needle hub 130 (as shown in FIG. 4g ) with the stylethub proximal portion 432 depressing spring 605 against the bias. Thisallows the stylet 319 to advance beyond the needle 116, as the trigger218 is continued to be pressed (as shown earlier in FIGS. 2d and 3c ).As the stylet hub 430 is advanced, it continues to press against theneedle release button 600, keeping it in the second or depressedposition 600B.

Automatic Interlock or Needle Release Button for Coupling and Decouplingthe Stylet and the Needle

In an alternate embodiment, as shown in FIGS. 4h-4i , an automatedsystem for coupling and decoupling the needle 116 and the stylet 319 isdisclosed. Similar to the embodiment of the needle release button 600described above, in the initial position, the needle release button 600couples the stylet hub 430 to the needle hub 130. The button 600 can bedepressed automatically for decoupling the two hubs. More specifically,the interference block 601 of the button 600 engages with the stylet hub430 when it is in its nominal or initial position 600A, as shown in FIG.4h . to couple the needle hub 130 to the stylet hub 430 during forwardtranslation. In some embodiments, the button 600 is coupled to theneedle hub 130 or is a part of the needle hub 130. Thus, as the stylethub 430 is advanced by actuation of the trigger, the needle hub 130 andthe button 600 advance along with it. The button 600 comprises anoverhang or hook 604 that rides over the handle body 14′ of the device.In other words the hook 604 rests against the handle body that definesthe inner chamber 140 (within which the stylet hub 430 and the needlehub 130 are located). The button 600 is retractable into the needle hub130, but cannot retract until the hook 604 is positioned within a notch142 defined within the handle body 14′.

As shown, for example, in FIG. 4i , a ramp 602 is provided on theinterference block 601 on its proximal face, and a corresponding ramp402 is provided on a distal face of the stylet hub 430, that interactswith ramp 602 of the interference block 601. As the stylet hub 430 isadvanced, for example, by pressing a trigger, ramp 402 of the stylet hub430 engages ramp 602 of the interference block 601, allowing the button600 (which includes interference block 601) to advance distally alongwith the stylet hub 430. The button 600 is advanced until the button 600is aligned with the notch 142, as shown in FIGS. 4j and 4k . In otherwords, the needle hub 130 is pushed/advanced by the stylet hub430/button 600 until the button 600 can retract out of the way into theneedle hub 130. Once the interference block 601 is positioned within thenotch 142, the interference block 601 is forced down by ramp 402 of thestylet hub 430, as it interacts with ramp 602 of the interference block601. The button 600 now moves from its initial position 600A to itssecond position 600B. This allows the stylet hub 430 to be advancedfurther distally relative to the needle hub 130, as shown in FIGS. 4land 4m . In other words, the portion of the stylet hub 430 that definesramp 402, slides over the needle hub 130, thus decoupling the needle hub130 from the stylet hub 430. As further shown in FIGS. 4n and 4o , thestylet hub 430 has advanced while the needle hub 130 has not.

Automatic Needle Release Button for Coupling and Decoupling the Stylet(Used in Conjunction with the Automatic Depth Selector with AudibleFeedback as Described Herein Below)

In some embodiments a needle release button 600′ is provided internal tothe handle body 14′. The needle release button 600′ initially locks theneedle hub 130 and the stylet hub 430 and is automatically depressed fordisengaging the two hubs, allowing the stylet 319 to be advanced beyondthe needle 116 (while the needle is blocked by the suture holder 316(FIG. 2d )). The embodiment of the needle/stylet interlock or needlerelease button 600′ is shown in FIGS. 6m-6x .′. Similar to embodimentsdescribed herein previously with respect to FIGS. 4j-4k actuation of thetrigger allows the stylet hub 430 to advance, and in its initial orengaged position 600A′ the interlock or needle release button 600′allows or forces the needle hub 130 to advance in unison with the stylethub 430. As discussed previously, FIG. 6m illustrates the device 100prior to a first actuation of the trigger and additionally shows theinterlock 600′ in its first position 600A′. Furthermore, FIGS. 6m (i), 6m (ii) and 6 m (iii) show a side bottom view of the device 100 showingthe needle release button 600′ in its initial position 600A′. FIGS. 6m(i) and 6 m(iii) show a cut-away view showing ramp 602′ provided on aproximal face of an interference block 601′, and a corresponding ramp402′ that is provided on a distal portion of the stylet hub 430, thatinteracts with ramp 602′ of the interference block 601. In oneembodiment, the proximal housing or handle body 14′ comprises a tab 1408that extends from the handle body 14′ into the handle inner chamber 140defined by the handle body 14′. When the needle release button 600′ isin its initial position as shown in FIG. 6m (ii), an overhang portion orhook 604′ of the button 600′ is positioned below the tab 1408 of thehandle body 14′ of the device 100. The tab 1408 may prevent the needlerelease button 600′ from being prematurely depressed upwards into itssecond position 600B′ and allows the stylet hub 430 and needle hub 130to be advanced together. In one example, the tab 1408 functions toprevent the button 600′ from being released by allowing the hook 604′ toabut against or engage with the tab 1408. The button 600′ is coupled tothe needle hub 130 and is retractable into the needle hub 130; however,the button 600′ cannot retract until the hook 604 ispositioned/translated past the tab 1408 defined within the handle body14′. In some embodiments, the needle release button 600′ is coupled tothe needle hub 130. The needle release button 600′ may be biased towardsits initial position 600A′ by a biasing means. In some examples, thebiasing means for the needle release button 600′ comprises a springbiased mechanism. In a particular example of this, the hook 604′ of theneedle release button 600′ is biased towards its initial position 600A′using a spring. The needle release button 600′ and particularly the hook604′ has the ability to retract, when the needle release button 600′ isin its depressed or second position 600B′, for example under applicationof a force. This allows the stylet hub 430 to be advanced furtherdistally relative to the needle hub 130. Each of these embodiments ofthe needle release button are described in greater detail hereinbelowwith reference to the device in use.

Mechanism for Controlling the Translation Distance of the Stylet

In some embodiments, an element for controlling the translation distanceof a suture passing element/suture holder retrieving element such as astylet 319 is provided, such that the translation distance of the suturepassing element at the first actuation of a trigger is different thanthe translation distance of the suture holder retrieving element at asecond actuation of the trigger. In order to allow for varying thedistance to which a stylet 319 is advanced when the trigger 218 isactuated, certain embodiments of the present invention provide a depthselection mechanism (depth selector) 500, 500′, as shown in FIGS. 5a-5e,6a-h , FIGS. 6i-6l and FIGS. 6m-6x . Thus, the depth selector 500 allowsvarious degrees of advancement of the stylet 319 in terms of how far itcan be translated relative to the needle 116. In some embodiments thedepth selector 500 fits into the stylet hub 430. The depth selectorcomprises a component that interferes with full advancement of thestylet 319, with the component capable of being positioned adjacent tothe stylet hub 430, distal to the stylet hub 430. This interferencecomponent may be a tab (as shown in FIGS. 5a-e and 6a-h ) and discussedfurther with respect to FIGS. 6i-6l . In other embodiments, theinterference component may comprise an arm with a stop as shown in FIGS.6m-6x . The depth selector may be actuated manually or automatically.

Manual Depth Selector for Controlling the Translation Distance of theStylet—(the Manual Depth Selector being Operational in Conjunction withthe Manual Needle Release Button Discussed Above)

FIGS. 5a and 5b illustrate the depth selector 500 is in itsfirst/initial or starting position or depth setting 500A and illustratethe starting and final (after trigger actuation) locations of the depthselection or adjustment mechanism 500 with respect to the handlehousing. With reference to FIG. 5c , the depth selector 500 extendstransversely with respect to the longitudinal axis of the device 100 andis coupled to the stylet hub 430. The depth selector 500 defines twopositions, a first position 500A and a second position 500B. In theinitial position 500A, an overhang or tab T of the depth selector 500 ispositioned adjacent the proximal portion 432 of stylet hub 430 and abutsagainst a distal face of the proximal portion 432 of stylet hub 430. Asshown in FIGS. 5c and 5d , In order to retain the depth selector 500 inits first position 500A, a projection 501 is provided on the depthselector that snaps into or otherwise engages with an indentation 502within the stylet hub 430. The projection 501 is held within theindentation 502 until a transversally directed force is applied againstthe depth selector, to move the depth selector into its second position500B.

With reference now to FIG. 5d , the depth selector 500 at its firstposition or initial depth setting 500A is positioned such that the tab Tis positioned adjacent the stylet hub proximal portion 432. Thus, thetab T is positioned distal to the stylet hub proximal portion 432between the distal surface of the stylet hub proximal portion 432 andthe needle hub 130, and interferes with full advancement of the styletin terms of how far it can be translated relative to the needle. Thisallows the stylet 319 to be advanced to a first predetermined distanceto deposit the suture knot 250 within the suture holder 316 but not toengage therewith.—The depth selector 500 is moveable into its secondposition by application of a transversally directed force F against thedepth selector 500, thereby moving the projection 501 of the depthselector into the second indentation 503 within the stylet hub, whichallows the depth selector to remain in its second position 500B. Withreference now to FIG. 6e , when the depth setting 500B of depth selector500 is in its second position the tab T of the depth selector 500 is notlocated between the distal surface of the stylet hub proximal portion432 and needle hub 130. In this position, the depth selector tab T doesnot interfere with the advancement of the stylet hub 430 relative to theneedle hub 130 and allows the stylet 319 to be advanced to a secondpredetermined distance to engage the suture holder to retrieve thesuture holder 316

Automatic Depth Selector for Controlling the Translation Distance of theStylet—(the Automatic Depth Selector being Operational in Conjunctionwith the Automatic Needle Release Button Discussed Above)

In some embodiments, as shown in FIGS. 6i-6l , the depth adjustment orselection mechanism may be automated. However, instead of requiring amanual transversally directed force to move the depth selector 500 fromits initial position 500A to 500B, an automatic mechanism is provided tomove the depth selector from its first position 500A to its secondposition 500B. As shown in FIG. 6i , a depth selector 500 is shown inits first position 500A, prior to the first trigger actuation of thetrigger. The device proximal portion or housing 14 additionallycomprises an arm 505 and a tab 506. When the depth selector is in itsfirst position the tab 506 rests on a first side of the arm 505 andprojection 501 of the depth selector is positioned within the firstindentation 502 within the stylet hub 430. The tab 506 is moveable pastthe arm 505 upon actuation of the trigger to advance the stylet hub 430.The automatic depth selector 500 functions in a manner similar to themanual embodiment described above to limit the translation of stylet hubproximal portion 432 distally within the handle chamber 140, thusallowing the stylet 319 to be advanced to deposit the suture knot 240within the suture holder 316. Upon release of the trigger, when thestylet hub 430 automatically retracts together with needle hub 130 toits initial position, the tab 506 is operable to hit the ramp 505 b ofthe arm 505 forcing the depth selector 500 to move into its secondposition 500B, as shown in FIGS. 6k and 6l . The tab 506 is positionedon a second side of the arm 505. The projection 501 of the depthselector 500 engages with the second indentation within the stylet hub430. The stylet hub proximal portion 432 may then be re-advanced with asecond actuation of the trigger to allow the stylet 319 to be advancedfurther to engage the suture holder 316 so that it can be retractedtherewith.

Automatic Depth Selector or Controlling the Translation Distance of theStylet with an Audible Feedback—(the Automatic Depth Selector withAudible Feedback being Operational in Conjunction with the AutomaticNeedle Release Button Discussed Above)

In some embodiments a depth selector is shown with an additionalmechanism for generating audible feedback is provided which indicateswhen the translation of each of the suture passing element and thesuture holder retrieving elements (to their respective distances) iscomplete. The suture holder passing element and the suture holderretrieving element can both translate to different distances whenactuated. In one embodiment, as shown in FIGS. 6m-6w , a U-shaped depthstop or depth selector 500′ is shown. As shown in FIG. 6m , the depthselector 500′ comprises a lower arm 507 and an upper arm 508, whichfurther comprises a stop 509. In a specific example, the depth selector500′ is pivotally coupled to the stylet hub proximal portion 432, forexample using a pin. Upward rotational movement of the depth selector500′ is prevented as it abuts against the stylet hub proximal portion432. Downward rotation movement of the depth selector 500′ may also belimited by providing a tab on the depth selector 500′ that engages withthe stylet hub 430. The handle body 14′ of the device, comprises depthselector control or guide ribs 1403, 1405 and click ribs 1404, 1406 thatface/project towards the interior of the chamber 140 defined by thehandle body 14′. In the initial position a tab 510 of the deflectablearm rests against an upper surface 1403 a of the control rib 1403.

In the initial position, the depth selector 500′ is positioned such thatarm 508 is positioned between the needle hub 130 and the stylet hubproximal portion 432. The stop 509 of arm 508 is operable to contact orabut against the needle hub 130 upon a first actuation of the trigger toprevent full translation of the stylet hub 430 with respect to theneedle hub 130. This allows the stylet 319 to be advanced distally to afirst predetermined position to deposit a suture knot 250 within thesuture holder 316 at the distal tip 12. Additionally the depth selector500′ comprises a lower arm 507 having a tab 510 that is moveable intoits deflected position during the first actuation of the trigger and ismoveable thereafter into its undeflected position, to allow tab 510 tohit rib control 1404 of the handle body 14′. This allows the depthselector 500′ to generate a “clicking” sound indicating the styletadvancement to its first desired distance is complete.

In its second position the depth selector 500′ is pivoted downwards sothat arm 508 is no longer positioned between the stylet hub proximalportion 432 and the needle hub 130, and does not interfere with fulladvancement of the stylet 430. This allows the stylet 319 to advancedistally to a second position to engage with the suture holder.Additionally the lower arm 507 is further moveable into its deflectedposition during the second actuation of the trigger and is moveablethereafter into its undeflected position, to allow tab 510 to hitcontrol rib 1406 of handle body 14′. This allows the depth selector togenerate a “clicking” sound indicating the stylet advancement to itssecond desired distance is complete.

In some embodiments the stylet hub proximal portion 432 may be anintegral part of stylet hub 430. In other embodiments, the stylet hubproximal portion 432 may be a separate component but is integrallycoupled with the stylet hub 430. In some examples, the stylet hubproximal portion 432 may comprise a material that differs from thestylet hub 430. In a specific example, the stylet hub proximal portion432 comprises stainless steel.

Each of these embodiments describing the depth selector 500 aredescribed in greater detail hereinbelow with reference to the device inuse.

Mechanism for Compensating for Deflection

The present device can include a mechanism for compensating fordeflection when translating a suture passing element or a sutureretrieving element through tissue from the device proximal portion 14 tothe device distal tip 12. In some examples, the device may comprise amechanism for compensating for deflection upon translation of a tissuepuncturing member of the device, such as a needle 116. In otherexamples, the device 100 may provide a mechanism for compensating fordeflection within another component, such as a longitudinally extendingneck portion 15 of the device (which may be a part of shaft 16 of thedevice proximal portion) which may cause distal tip 12 to deflect. Thedeflection may be a result of the tissue resisting advancement of theneedle 116 or stylet 319 or the resistive force of the tissue acting atthe distal tip 12. In some examples, deflection of needle 116 or thedistal tip 12 may cause the needle 116 to become misaligned from chamber12B which may, for example, prevent a suture passing element such as astylet housed within the needle 116 to pass a suture into the distal tip12.

In one embodiment a feature is provided for compensating for deflectionof the tissue puncturing member. In one specific example, the tissuepuncturing member comprises a needle 116 housed within shaft 16. Thefeature for compensating for deflection of the needle 116 comprisesproviding an offset between the needle 116 and chamber 12B. As shown inFIG. 3e , the needle 116 is advanced from the shaft 16 of the deviceproximal portion 14 to the distal tip 12 to puncture tissue positionedwithin the tissue receiving gap 10. As the needle 116 penetrates thetissue, the tissue applies a resistive force (F_(tissue)) to the needle116. In a specific example as shown, the needle 116 has a non-symmetric(For example, bevel) geometry. As a result a component of the appliedresistive force (F_(tissue)) acts normal to the longitudinal axis orcenterline of the needle (F_(reaction)). This normal force(F_(reaction)) deflects the needle 116 from its centerline. As a resultthe needle 116 may be bent as it is being used to puncture or penetratethe tissue and is thus may become aligned with chamber 12B of the distaltip 12. In some examples, the needle 116 is deflected away towards thetop of the device as shown as shown by directional arrow M1. Thus, theneedle 116 may then be aligned substantially collinearly with thechamber 12B. Alternatively the needle 116 is deflected such that the tipof the needle 116 engages the opening of the chamber 12B, and thecontinued advancement of the needle 116 substantially collinearly alignsthe needle 116 with the chamber 12B as the bevel of the needle 116results in deflection towards the top of the device as shown as shown bydirectional arrow M1.

In another embodiment, a means is provided for compensating fordeflection of the device distal tip 12. Similar to the embodimentdescribed above, the feature for compensating for deflection of theneedle 116 comprises providing an offset between the needle 116 andchamber 12B. In another specific example, as shown in FIG. 3f , as thedevice 100 is positioned within tissue 200, the distal tip 12 mayencounter resistance, such a resistive force that is encountered whenthe distal tip hits bone (F_(bone)). If a counter force is appliedagainst this resistive force by the user using the device tip 12, a thinportion of the shaft 16, such as longitudinally extending neck portion15, may bend. In some examples, the distal tip 12 may bend away or maybe deflected towards the bottom of the device (as shown by directionalarrow M2). As a result the distal housing or chamber 12B defined bydistal tip 12, (which the needle 116 is targeting) may be moved. Thus, aforce applied by the user using the distal tip 12 may bend a portion ofthe shaft 16, aligning chamber 12B of the distal tip 12 with the needle116. In other words the needle 116 and chamber 12B may becomesubstantially collinear.

In further detail, in accordance with an embodiment of the presentinvention as shown in FIG. 3g , a device 100 is provided that allows theneedle 116 to be aligned with chamber 12B of distal tip 12 in itsintended trajectory. More specifically, a device is provided wherein thedistal tip 12 and the needle 116 are misaligned, in order to compensatefor the misalignment created by deflection of either the distal tip 12or the needle 116. More specifically, the device 100 provides a chamberor channel 16B defined by the shaft 16 of the proximal housing, chamber16B having a longitudinal axis or centerline L_(p). The device 100further comprises a chamber 12B defined by the distal tip 12 of thedistal housing, chamber 12B having a longitudinal axis or centerlineL_(d). According to an embodiment of the present invention, device 100provides that the centerline L_(p) of the shaft chamber 16B is offsetfrom centerline L_(d) of the distal tip chamber 12B. The chamber 12B isoffset or misaligned in the direction of needle and shaft deflection asshown, so that the deflected needle 116 still targets within the chamber12B within the distal tip 12.

In an alternate embodiment, other features may be provided to counterdeflection of the tissue puncturing member or a portion of the shaft. Inone specific example as shown in FIG. 3h , a pre-curved needle 116′ isprovided. The device 100 as shown in FIG. 3h , comprises a distal tip 12defining chamber 12B and a shaft 16 defining chamber 16B, where thecenterline L_(p) of chamber 16B is aligned with or substantiallycollinear with centerline L_(d) of chamber 12B. The curved needle 116′can accommodate or compensate for the deflection of either the distaltip 12 due bending of the neck portion 15, or deflection of the needleitself due to resistance force applied by the tissue. In one example,where the distal tip 12 is deflected downwardly, since the trajectory ofthe curved needle 116′ is such that it deflects into the tissuereceiving gap 10, the distal end of the curved needle 116′ is alignedwith the distal tip 12. In another example, where the curved needle 116′is deflected away from tissue receiving gap 10 due to tissue resistance,the resistive force applied by the tissue may straighten the curve ofthe needle 116′, thus allowing the needle 116′ to be aligned with thedistal tip 12.

In some embodiments described above, once a distal end or tip of theneedle 116 enter the chamber 12B within the distal tip 12, furtherdistal translation force/slides the needle 116 into the chamber 12B. Insome examples, a bevel provided on the needle end face allows the needle116 to slide into chamber 12B, to allow the distal end the needle to besubstantially collinear with chamber 12B. In some embodiments, theneedle 116 assumes a slight curve or an s-shaped configuration as it isforced or slid into chamber 12B.

An Exemplary Suture Passing Member in Accordance with an Embodiment ofthe Present Invention

An embodiment of the stylet 319 is described with reference to FIGS.7a-7d , the stylet 319 comprising features for engaging the sutureholder 316. The engagement between suture holder retrieving member suchas the stylet 319 and the trap 416 may be further enhanced by theprofile or configuration of stylet 319. In some embodiments, the sutureholder retrieving element such as stylet 319 may comprise an engagementfeature that co-operatively engages with the suture holder 316 such asthe trap 416. The engagement feature may comprise a recess or groovethat engages with fingers of the trap 416. In other embodiments theengagement feature may comprise a protrusion that engages with thefingers of the trap 416. In one example, a stylet 419 is provided asshown in FIGS. 7a-7e . The stylet 419 comprises a stylet tip 420 and astylet shaft 424. A portion of the stylet tip 420 has a width W2. Aportion of the stylet shaft 424 adjacent and proximal to the stylet tip420 has a width W1. The width W2 along a portion of the stylet tip 420being greater than width W1 along a portion of the stylet shaft 424. Theportion of the stylet tip 420 having width W2 being defined as thestylet tip wider region 421. And the portion of the stylet shaft 424having width W1 being defined as the shaft narrower region 423. Ashoulder or edge 426 may form at the interface between the stylet tipwider region 421, and the stylet shaft narrower region 423. In otherwords the stylet tip wider region 421 defines a shoulder or edge 426. Asmentioned above, in some embodiments, a protrusion forms the engagementfeature of stylet 419. As an example of this the protrusion is formed bythe stylet tip wider region 421. In a specific example, the engagementfeature comprises the shoulder or edge 426 defined by the stylet tipwider region 421. In one embodiment, wherein stylet 419 has asubstantially circular cross-section, the stylet tip wider region 421 isof a substantially greater diameter than the stylet shaft narrowerregion 423.

In one example, wherein the stylet has a reduced profile substantiallyalong the length of the stylet shaft 424 the stylet shaft may have asubstantially rectangular cross-section or a partially rectangularcross-section along portions thereof. In a specific example of this asis further illustrated in FIG. 7e , the stylet shaft 424 has four flatsor planar surfaces 425 that form the reduced rectangular cross-sectionalong the distal portion of the shaft 424 along the shaft narrowerregion 423. Furthermore shaft 424 has a partially rectangularcross-section along the shaft portion 427, with a portion of the shaftcross-section being rounded or circular. In other embodiments, the shaftnarrower region 423 may have any other cross-sectional shape which maynon-limitingly include any one of a circular, oval or squarecross-section or combinations thereof.

In operation, the stylet 419, functioning as the suture holderretrieving member is advanced to capture the trap 416. The stylet isadvanced through the trap 416 such that the shoulder or edge 426 definedby the stylet tip wider region 421 advances past a distal opening of thetrap 416 (FIG. 7d ). The distal opening of the trap 416 is defined byfingers 322 that substantially converge at the distal end, the fingers322 having a nominal shape and position. In some embodiments, the trap416 is resilient and the fingers 322 flex as the stylet tip 420 isadvanced past the distal opening of the trap 416, and returnsubstantially to their nominal shape/position when the stylet tip 420 ispositioned distal to the trap 416 (i.e. when the shoulder or edge 426 ispositioned distal to the trap 416). When the trap 416 has returnedsubstantially back to its nominal shape/position, the distal opening ofthe trap 416 has a smaller width than the width along the stylet tipwider region 421. Thus, when the stylet 419 is retracted, the shoulderor edge 426 of the stylet tip wider region 421 abuts against the narrowdistal end of the trap 416, thereby preventing the stylet tip 420 fromretracting back through the trap 416. The stylet 419 and the trap 416are then retracted together as a unit, through tissue site P2 throughthe second segment of tissue 200. In alternate embodiments, the sutureholder 316 may comprise a trap 416 having fingers 322 and the sutureholder retrieving member such as stylet 319 may comprise an indent whichengages with the fingers of the trap 416. Alternatively, the stylet 319may comprise any other feature that allows the stylet 319 to engage asuture holder 316.

Put differently, an engagement mechanism may be provided between thestylet 319 and the trap 416 that enables the trap 416 to be retractedalong with the stylet 319 as the stylet 319 is retracted, allowing fordisengagement of the trap 416 from the distal tip 12, as shown in FIG.3d . This allows the suture knot 250 to be withdrawn proximally througha second side of the tissue, for example through tissue site P2 usingthe trap 416. The suture 240 is passed from the distal side to theproximal side of the tissue through the second segment of the tissue.Thus, this allows the suture 240 to be passed through tissue on bothsides of the defect to allow the two sides of the tissue to beapproximated in order to substantially seal the defect.

An Exemplary Suture Trap in Accordance with an Embodiment of the PresentInvention

As illustrated and discussed in greater detail below, in someembodiments the suture holder 316 defines an opening on its distal side.The suture holder 316 is capable of receiving the stylet 319 that pushesthe knot 250 through such that it exits through the opening thereof. Insuch an example, the opening on the distal side of the suture holder 316is defined by the suture retaining means. In other words, the sutureretaining means may be understood to be the portion of the suture holderdefining the distal opening through which knot 250 is positioned. Onespecific embodiment of the suture holder 316 for receiving a knot 250 isdescribed with reference to FIGS. 7a-7c . In one specific example, asshown in FIG. 7a , the suture holder 316 described herein above maycomprise a trap 416. The trap 416 allows a suture holder retrievingmember, such as the stylet 319 to engage the trap 416 when the stylet319 is advanced to a second predetermined distance or in the second pass(FIGS. 3c-3d and FIG. 7d ) to allow the trap 416 to be retracted withthe stylet 319. The trap 416 is formed from a tubular hollow elongatemember terminating in flexible tips or fingers 322. The tips or fingers322 which may be elastic or resilient, form the suture retainingcomponent of the trap 416. As mentioned above, in the first pass, thestylet 319 is advanced through tissue on a first side of the defect topass the suture 240 there-through. As the stylet 319 is advanced throughthe trap 416, the flexible elastic fingers 322 of the trap 416 formingthe suture retaining component flex to allow the stylet 319 to pass theknot 250 through the trap 416 (FIG. 7b ). The fingers 322 subsequentlyreturn to their nominal position when the stylet 319 is retracted, totrap and retain the knot 250 in a position distal to the trap 416 (FIG.7c ), which in one example, may be beyond the device distal tip 12.Thus, the trap 416 allows the knot 250 to travel through the trap in onedirection and retains the knot 250, preventing proximal movement of theknot 250 through the trap 416. In one embodiment, the suture retainingcomponent of the trap 416 comprises at least four fingers 322. In analternate embodiment, the suture retaining component of the trap 416comprises at least three fingers 322. In one specific example, whereinthe suture holder 316 includes a trap 416, trap 416 comprises a bevel atits proximal end face (a beveled proximal face) to allow engagement withthe bevel at the distal end of the needle 116 (beveled distal face)according to one embodiment as described above,

Alternative Embodiments of the Suture Trap and Corresponding EngagementFeatures within the Distal Tip

Alternative embodiments of the device of the present invention are shownbelow with respect to FIGS. 9-19. Each of these embodiments may be usedin conjunction with the method described herein below with reference toFIGS. 2 and 3. The term “suture holder” as used throughout refers to asuture trap 316 operable to capture a suture passed therethrough by asuture passing member.

In a further embodiment, as shown in FIGS. 9a-9f , a device 100 is usedto practice a method of the present invention to treat a defect. Thedevice 100 comprises a suture holder 316 at a distal tip thereof. Thesuture holder 316 may be releasably coupled to the distal tip 12 usingany of the member engagement features described herein. For example, thesuture holder 316 may be coupled to the distal tip 12 using co-operativeengagement between the suture holder 316 and distal tip 12 or using awire that passes through the distal tip 12 into an aperture of thesuture holder 316. The suture holder 316 may at least partially define alumen there-through. In one embodiment the suture holder 316 has asuture retaining component for remotely capturing and/or retaining aportion of the suture. The suture portion may be captured remotely fromthe user during a medical procedure. In one example, the sutureretaining/capturing component comprises one or more resilient fingers(or ‘spring biased appendages’) that are inwardly biased with respect tothe suture holder. The suture retaining component comprises one or moreresilient members or fingers that project from (a surface) of the sutureholder to effect, direct or restrain motion when brought into contactwith a second object. In another example, the one or more resilientfingers effect, direct or restrain motion of a portion of the suture. Ina specific example of this, the fingers project sufficiently inwards toprevent retraction of the suture portion. In one example, the sutureportion is taken from the group consisting of a suture knot, a sutureball, a metal tab or a plastic tab. The suture retaining component maycomprise one finger. Alternatively, the suture retaining component maycomprise more than one finger. In some examples, the suture retainingcomponent may comprise two, three, or four fingers. In one embodiment,the inwardly biased fingers are located at a distal end of the sutureholder. In an alternate embodiment, the one or more fingers arepositioned at a location along the longitudinal length of the sutureholder. In one example of this, as shown in FIGS. 9a-9b and 9c , thesuture holder 316 has one or more resilient arms or finger 322 that maybe bent or tapered towards the interior of the suture holder 316 atabout a mid-length of the suture holder 316. In a specific example, thesuture holder 316 has one arm or finger 322. In some embodiments, thefingers 322 may be referred to as protrusions, members or tips.

The device 100 further comprises a suture passing member in the form ofa stylet 319 that has a groove 428 along its distal portion. The stylet319 is housed within a hollow needle 116 that functions as a tissuepuncturing member. A portion of the suture 240, such as knot 250 is heldwithin the needle 116 in the device proximal portion, as shown in FIGS.9a-9b, and 9c . The distal end of stylet 319 is equipped for pushing thesuture knot 250 into suture holder 316 as shown in FIG. 9d uponadvancement of the stylet 319 to a first predetermined distance. Theresilient arm or finger 322 of the suture holder 316 is capable offlexing to allow passage of stylet through the suture holder 316 asshown in FIG. 9e . Thus, the suture holder 316 may additionally functionto restrict movement of the suture passing member such as stylet 319,such that it allows the suture passing member to advance till it allowsthe suture knot 250 to engage the suture retaining component and thesuture passing member is free to retract there-from as shown in FIG. 9e. The suture holder 316 may additionally function to restrict movementof the suture holder retrieving member, such as stylet 319 such that itcan engage stylet 319 upon readvancement of stylet 319 to a seconddistance. This allows the suture the stylet 319 to retract the sutureholder 316 there-with as shown in FIG. 9f . The resilient arm or finger322 of the suture holder 316 is received within and engages the groove428 of stylet 319, allowing capture of the suture holder 316 by thestylet 319 (FIG. 9g ). In this position the suture holder 316 restrictsmovement of the stylet 319 by allowing the groove 428 to engage with thefinger 322 of the suture holder 316. In one embodiment as shown in FIG.9f , the suture holder may comprise tabs that are held within a window128 of the distal tip 12 to allow the suture holder to be coupled to thedistal tip 12. In an alternative of the above described embodiment, thestylet 319 may be rotatable to change its orientation between first andsecond orientations. In its first orientation, such groove 428 of thestylet 319 faces away from the arm or finger 322, as shown in FIG. 9h .This may help prevent the groove 428 of the stylet 319 from engaging thearm or finger 322 during initial advancement of the stylet 319, thusensuring that the stylet 319 can be retracted freely after the knot 250is deposited at the suture holder 316. Thus, in its first orientationthe stylet 319 is in its non-engaging orientation where it cannot engagethe suture holder 316 as it is advanced. In its second orientation, thestylet 319 is in its suture holder engaging orientation where the groove428 is positioned on the same side as the arm or finger 322 so thestylet 319 may engage the suture holder 316 upon re-advancement. The,the arm or finger 322 of the suture holder 316 is operable to fit intoor engage the groove 428 of the stylet 319, which may allow the styletto retrieve the suture holder 316 upon retraction, as shown in FIG. 9i .Thus, the arm or finger 322 of the suture holder 316 functions torestrict or restrain the motion of the stylet 319 and allows engagementof the stylet 319 with the suture holder 316.

In another example of an embodiment of the present invention as shown inFIGS. 10a-10f , the device 100 comprises a suture holder 316 that isdisposed at the device distal tip 12. The suture holder 316 comprises ahollow tubular member defining a lumen there-through. The suture holder316 comprises a suture retaining component such as one or more inwardlybiased resilient fingers that project from a surface of the sutureholder 316 at a distal end thereof. The fingers 322 function to effect,direct or restrain motion of a portion of the suture passed through thesuture holder 316. The fingers 322 additionally also function torestrict motion of the suture passing member used to pass the sutureportion through the suture holder 316, and further to engage the sutureholder retrieving member that is passed thereafter through the sutureholder 316 to retrieve the suture holder 316 with the suture portioncoupled thereto.

Additionally, the suture holder 316 comprises an engagement feature forreleasably coupling the suture holder 316 to the device distal tip 12.The engagement feature comprises co-operative engagement between thesuture holder 316 and the device distal tip 12. In one example, thesuture holder 316 has an indent, a recess or groove 321 thatco-operatively engages with a projection 121 of the distal tip 12, toallow the suture holder 316 to be releasably coupled to the distal tip12, as shown in FIG. 10a . The engagement feature allows suture holder316 to remain detachably engaged with the suture holder 316 duringadvancement of stylet 319 to pass suture 240 and retraction thereafteras shown in FIGS. 10b and 10c . The disengagement of the projection 121of the distal tip 12 with the indent, recess or groove 321 of the sutureholder 316 may be affected by rotation of the suture holder 316 usingstylet 319 after it has been re-advanced through the suture holder 316as shown in FIGS. 10d and 10e , thereby allowing suture holder 316 to beretracted through tissue on the opposing side of the defect using thesuture holder retracting member such as stylet 319, as shown in FIG. 10f.

A further alternate embodiment is shown in FIG. 11a , with the sutureholder 316 disposed at the device distal tip 12 and is received within areceiving chamber of the distal tip 12. The suture holder 316 comprisesa suture retaining component in the form of one or more fingers 322, asdescribed previously to retain a portion of the suture 240 that ispassed by the suture passing member into the suture holder 316. Thesuture holder 316 further comprises an engagement feature allowing it tobe detachably coupled to the device distal tip 12. The engagementfeature comprises a notch or an engaging surface 330 that co-operativelyengages with a projection at the distal tip 12, to retain the sutureholder 316 within the receiving chamber of the distal tip 12. In onespecific example, the projection at the distal tip 12 is a projection131 of a spring clip 132, with the spring clip 132 being coupled to thedistal tip 12, as shown in FIG. 11a . The suture holder 316 comprises asuture retaining member such as fingers 322, to capture and retain thesuture knot 250 therein. Furthermore, the stylet 319 may comprise anengagement feature to order to allow the stylet 319 to engage the sutureholder 316, as shown in FIG. 11b . For example similar to embodimentsdiscussed previously, the stylet 319 may have a tip wider region thathas a width that is greater than the width along the distal end of thesuture holder 316 for engaging with the suture holder upon advancementof the stylet tip wider region through and distal to the suture holder316. In order to enable retraction of the suture holder 316, a mechanismis provided to disengage the suture holder 316 from the distal tip 12.As shown in FIGS. 11c and 11d , in one example, the needle 116 thathouses the stylet 319, may be rotatable (for example by 90 degrees) toallow the suture holder 316 to rotate with the needle 116 allowing thenotch or engaging surface 330 to be rotated out of engagement with theprojection of the spring clip 132, thus decoupling the suture holder 316from the distal tip 12. This ensures that the notch or engaging surface330 no longer faces the clip 132; instead, the spring clip 132 isadjacent and in contact with a non-engaging surface of the suture holder316, (which in one particular example may be a smooth outer surface ofthe suture holder 316). This allows the stylet 319 (as the suture holderretrieving member), as well as the suture holder 316, to be retractedwith limited, reduced or substantially no hindrance.

In accordance with an alternate embodiment of a method of the presentinvention, a device 100 shown in FIG. 12a may be used The suture holder316 may be detachably coupled to the distal tip 12 using co-operativeengagement. The suture holder 316 additionally comprises a sutureretaining component where the suture retaining/capturing componentcomprises an element of the suture holder 316 that at least partiallydefines an aperture. In some embodiments the suture retaining componentcomprises a wall of the suture holder 316 that defines an aperture. Insome embodiments, an edge 327 b of the wall defines the aperture andforms a proximal boundary of the aperture. In alternate embodiments, theaperture may be any one of a rectangular aperture, an oblong aperture ora key-shaped aperture. In some embodiments, the aperture may be referredto as a slot, a window, an opening or a hole. In some embodiments, thesuture holder 316 defines a hollow lumen at least partiallythere-through. In one example, the suture holder 316 defines a lumenthat extends completely there-through. In some embodiments, the sutureretaining component comprises a distal face of a wall of the sutureholder 316, the distal face defining the aperture. In one example, theaperture extends transversally within the wall of the suture holder 316.In other examples, the aperture extends longitudinally within the wallof the suture holder 316. In some embodiments, the aperture extends bothtransversally and longitudinally. In one specific example, the apertureis an L-shaped slot 323 having a transversally extending portion 323 bthat is formed distally to longitudinally extending opening 323 a. Aportion of the suture 240 may be passed into the slot 323 through thelongitudinally extending opening 323 a. The suture portion may then beretained by the suture retaining component within the transversallyextending portion 323 b of the slot. In one particular example, thesuture retaining component comprises an edge 327 b of the suture holderwall that forms the proximal boundary of the slot 323.

As shown in FIGS. 12a-12d , in order to facilitate the transfer of thesuture portion from the device proximal portion to the suture holder 316at the distal tip 12, the device 100 further comprises a suture passingmember. In one particular embodiment the suture passing member comprisesan elongate needle 116 that defines an opening 123 for carrying aportion of the suture 240. In one example, the suture portion is asuture knot 250. In an alternate embodiment, the suture portioncomprises a tab 260 which may be a metal or a plastic tab affixed to afree end of the suture.

In operation, the device 100 is insertable through a defect within aregion of tissue, such that the suture holder 316 (coupled to the devicedistal tip 12) is positioned on a distal side of a first segment oftissue (Not shown). The needle 116 (functioning as the suture passingmember) may be advanced through the first segment of tissue to depositthe suture portion within the suture holder 316. As shown in FIG. 12b ,the needle is advanceable to a first distance (which may be apredetermined distance) such that the suture tab 260 or knot 250 isreceived within the longitudinally extending opening 323 a of slot 323of the suture holder 316. The distal portion of the needle 116 isreceived into the suture holder 316 but the raised portion or projection125 of the needle 116 does not engage with the suture holder 316. Theneedle 116 may then be rotated 180 degrees (e.g. counterclockwise) totranslate the suture tab 260 or knot 250 within the slot portion 323 baway from the slot opening 323 a to secure the suture tab 260 within thesuture holder 316, as shown in FIG. 12c . As shown in FIG. 12d , theneedle 116 may then retracted and rotated by another 180 degrees (e.g.clockwise) after having passed suture 240 through the first segment oftissue on one side of the defect.

In operation, the device 100 may then be re-positioned on the other sideof the defect. In other words the device 100 is re-positioned such thatthe suture holder 316 is now positioned on a distal side of a secondsegment of tissue. The needle 116 (now operating as the suture holderretrieving member) is then re-advanced and passed through the secondsegment of tissue. As shown in FIG. 12e , the needle 116 is advanceableto a second distance (which may be a predetermined distance). The needle116 advanced further distally relative to the distance traveled byneedle 116 in FIG. 12b . This allows the raised portion or projection125 of the needle 116 to be positioned within the suture holder 316. Theneedle 116 may then be rotated 180 degrees (e.g. counterclockwise) tolock the needle 116 and suture holder 316 together. In this particularexample, when the needle 116 is rotated the projection 125 of the needle116 is received within/engages a portion of the suture holder 316, suchas a recess or a groove or a window 317 as shown. The needle 116 is thenretracted, disengaging the suture holder 316 from the distal tip 12.Both the needle 116 and the suture holder 316 can then be withdrawntogether through the defect (FIG. 12f ), thereby passing suture 240coupled to the suture holder 316 through tissue on the second oropposing side of the defect. Thus, device 100 can allow suture 240 to bepassed through both the first and second segments of tissue on opposingsides of the defect. FIGS. 13a-13d illustrate a device 100 in accordancewith still another embodiment of the present invention for passing asuture through tissue using. Similar to embodiments discussed hereinabove, the device 100 comprises a suture holder 316 coupled to thedevice distal tip 12 (not shown). The device 100 additionally comprisesa means for passing a portion of the suture from the device proximalportion to the suture holder 316 at the device distal tip 12. Asdiscussed previously, the suture holder 316 comprises both an engagementfeature for detachably coupling the suture holder 316 to the devicedistal tip 12, as well as a suture retaining component for receiving andretaining the suture portion. Generally, the suture retaining componentof the suture holder 316 comprises an aperture defining element of thesuture holder 316. In one embodiment, the suture retaining componentcomprises an aperture defining wall of the suture holder 316. As anexample of this, the suture retaining component forms/defines an edge ofthe aperture.

In one particular embodiment, the suture retaining component comprises adoor, i.e. a hinged, sliding or revolving barrier that forms an edge ofthe aperture. The barrier is positioned substantially perpendicularlybetween opposed edges of the aperture. Additionally, the barrier ismoveable between an open position and a closed position, where thebarrier in its open position allows access to the aperture for receiptof the suture portion therein. In a specific example of this, thebarrier forms a side edge of the aperture. In another example, thebarrier forms a proximal edge of the aperture. More specifically, thesuture holder 316 defines a longitudinally extending slot 323 with thesuture retaining component comprising a barrier or flap 325 at theproximal opening of the slot 323. In some embodiments, the barrier maybe hinged or pivotable. As an example of this, the barrier is biasedtowards its closed position. Furthermore, the bias may be provided usinga spring biased mechanism. In one example, the barrier 325 is coupled tothe suture holder 316 using a spring that biases the barrier towards itsclosed position.

The operation of the device in use is discussed further herein below. Asthe needle 116 (carrying knot 250) is advanced through a first side ofthe tissue and into the suture holder 316, the knot 250 pushes againstthe hinged barrier 325, causing the hinged barrier 325 to open towardsthe interior of the slot 323 to receive the knot 250, as shown in FIG.13b . As the knot 250 moves past the open hinged barrier 325, the hingedbarrier 325 closes, and returns to its nominal closed position (FIG. 13c). In one example, a stopper S may be provided that prevents the barrierfrom opening towards the exterior of the trap and allows the barrier toremain in the closed position. When the needle 116 is retractedproximally, the suture knot 250 is retained in the slot 323 by thehinged barrier 325 (FIG. 13d ). The suture holder 316, and subsequentlythe knot 250 retained therein, may then be retracted through tissue onan opposing side of the defect using a suture holder retrieving memberas discussed for any of the embodiments described herein. In onespecific example, the suture holder retrieving member comprises a needle116. The needle 116 comprises a projection or tooth 125. The needle 116is advanced to retrieve the suture holder 316. As the needle 116 isadvanced into the suture holder 316, the tooth 125 is received within alumen 13′ of a longitudinally extending shaft 13 within the sutureholder 316. The needle 116 is not free to rotate as the movement of theneedle 116 is restricted to longitudinal advancement due to theinteraction of the tooth 125 with lumen 13′. Once the needle 116 isfully advanced within the suture holder 316, the tooth 125 is positionedadjacent a groove or window 317 of the suture holder 316. As the needle116 is then rotated, the tooth 125 is received within the groove orwindow 317 and engages therewith. This couples the needle 116 to thesuture holder 316 enabling the needle 116 and the suture holder 316 tobe retracted together.

In an alternate embodiment, the hinged barrier 325 may be replaced by aresilient member or tab 1325A, as shown in FIG. 13e . The materialproperties of the tab 1325A may allow it to return substantially to itsnominal or resting position. In some embodiments the tab 1325A maycomprises an elastomer. In one specific example the tab 1325A comprisessilicone. In some embodiments, suture holder 316 may comprise aplurality of tabs. In one specific example, suture holder 316 comprisestwo tabs such as tabs 1325A and 1325B, shown in FIG. 13f and FIG. 13g .In another example, the suture holder 316 comprises three tabs. In otherembodiments, the suture holder 316 may comprise more than three tabs.

In still another embodiment as shown in FIGS. 14a-f , a device 100 isdisclosed for passing suture for example to treat a defect, wherein thedevice comprises a suture holder 316 coupled to a distal tip of thedevice 100. The suture holder 316 in some embodiments may define a lumenat least partially there-through. The suture holder comprises a sutureretaining component for capturing and retaining the suture. In someembodiments, the suture retaining component comprises a wall defining anaperture such as a slot 327, which in one example is positioned at oradjacent a distal end of the suture holder 316. The slot is defined byan edge 327 b of the wall that is proximal to the slot 327 and forms theproximal boundary of the slot 327. In other words, the suture retainingcomponent comprises a distal face of a wall of the suture holder 316where the distal face defines the aperture. Furthermore, the sutureholder 316 further comprises an engagement feature for coupling thesuture holder 316 to the device distal tip 12 for example, throughco-operative there-between. In some embodiments, the suture holder 316comprises a projection that is received within a notch or a recess ofthe distal tip 12. As an example of this, the projection on the sutureholder 316 comprises a fin 328. Thus, the suture holder 316 is retainedwithin the device distal tip by the fin 328 being received within a slotor groove of the distal tip 12. The device 100 further comprises aneedle 116 carrying a suture knot 250 of the suture strand 240, as shownin FIG. 14 a.

In operation, the device 100 is inserted through a defect within thetissue in order to treat it. The device distal tip 12 is positioned on afar side of the tissue and positioned such that a first segment oftissue 200 is received the tissue receiving gap 10 (not shown). As shownin FIG. 14b , the needle 116 is then advanced through the first segmentof tissue on one side of the defect, to a first distance such that it isreceived within the suture holder 316 and the knot 250 is positioneddistal to the suture holder 316, as shown in FIG. 14b . The needle 116is then rotated by 180 degrees (e.g. counterclockwise) with respect tothe suture holder 316 such that the knot 250 is longitudinally alignedwith the slot 327, and then withdrawn, as shown in FIGS. 14c and 14d .As the needle 116 is retracted, the knot 250 abuts against the edge 327b forming the proximal boundary of slot 327 and is retained within theslot 327. The needle is then rotated, e.g. clockwise, by 180 degrees.The device 100 is then re-positioned at tissue on a second side of thedefect. The device further comprises a suture holder retrieving memberthat is housed within the proximal portion and advanced distally toretrieve the suture holder 316. In one particular example, as shown inFIG. 14e , the needle 116 also functions as the suture holder retrievalmember and is then re-advanced through tissue and into the suture holder316 to a second location (which requires advancing a greater distance(distally) relative to the distance traveled by the needle 116 withrespect to FIG. 14b ). A raised portion or projection 125 of needle 116is received within the suture holder 316 and the needle 116 is thenrotated 180 degrees (e.g. counterclockwise) to allow the projection 125to engage a window or aperture defined by a wall of the suture holder316. This allows the needle 116 to engage the suture holder 316 whilesubstantially simultaneously allowing the fin 328 of the suture holder316 to disengage from the device distal tip. The needle 116 can then bewithdrawn or retracted, thereby drawing the suture holder 316 and suture240 through tissue on the second side of the defect.

In another embodiment of the present invention, a device 100 isdisclosed having a suture holder 316 coupled to the device distal tip12. The suture holder 316 may comprise a resilient material such as anelastomer, plastic or metal such as stainless steel. In some embodimentsthe suture holder 316 may comprise a resilient material that is capableof elastic deformation when force is applied to it and is capable ofreturning substantially to its original position when the force isremoved. In some embodiments, the suture holder 316 comprises a valve1516. In one example, passage of material/object through the valve 1516in a first direction exerts an internal force which causes it to open.Whereas, retraction of material/object in the opposing direction exertsa force on the valve 1516 from the outside preventing the return passageof material/object therethrough. In one specific example the valve 1516is formed of an elastomer such as silicone. In another specific examplethe valve 1516 is formed of a metal such as stainless steel.

FIG. 15a . is an illustration of a valve 1516 comprising resilientmaterial. FIG. 15a shows the valve 1516 with fingers or flaps 1522 a and1522 b at rest, when no force is applied. In some examples, when forceis applied on the inside of the valve or internal pressure is applied,it causes the two fingers 1522 a and 1522 b to separate and may causethe two faces to stretch away from each other as shown in FIG. 15b . Forexample, as described previously, the two fingers 1522 a and 1522 bseparate as the knot 250 is pushed through the valve 1516 for example,using a stylet 319. Once the knot 250 is passed through the valve 516,the fingers 1522 a and 1522 b return substantially back to their restingposition. In some embodiments, as shown in FIG. 15c , the internal forcemay be removed allowing the valve to return substantially to itsresting/nominal position. Additionally, in some embodiments, as furthershown in FIG. 15c , an external force may be applied to fingers 1522 a,1522 b which may assist in returning the fingers substantially to theirnominal position. In one example, the valve 1516 may be closed using apull wire. In other examples, alternative means may be used to close thevalve 1516, such as an electromagnetic means or a mechanically drivenmeans.

In an alternate embodiment, the suture holder 316 may comprise a valve,For example, a duckbill valve 1616 as illustrated in FIG. 16. In someexamples, a duckbill valve 1616 may generally comprise an elastomericmaterial. In other examples, the duckbill valve 1616 may comprise othermaterials such as plastics or metals such as stainless steel. In oneexample the duckbill valve comprises two fingers or flaps 1622 a and1622 b that are joined together along their sides along the length ofthe duckbill valve 1616. A slit or opening 1627 is formed at the distalend of the valve 1616. The opening of slit 1627 is formed along thedistal face of the valve, between the two fingers or flaps 1622 a and1622 b.

In some embodiments, the suture holder 316 comprises a valve 1716comprising two fingers or flaps 1722 a and 1722 b, as shown in FIG. 17,with a longitudinally extending slot 1729 extending there-between alonga portion of their length. The valve 1716 functions to allow passage ofmaterial or object there-through in a first direction, but prevents themovement or flow of the material or object there-through in a seconddirection substantially opposite to the first direction. In one example,the slot 1729 extends substantially along the length of the valve 1716.The two fingers 1722 a and 1722 b are coupled by the proximal portion1720 of the valve 1716. In one example, the proximal portion 1720comprises elastic properties. This allows the two fingers 1722 a and1722 b to remain closed in their resting position, but allows them toopen—for example to allow passage of a stylet 319 therethrough. In onespecific example as shown in FIG. 17, the slot 1729 does not extendalong the proximal portion 1720 of the valve 1716 and the proximalportion 1720 comprises a continuous cylindrical/tubular section thatextends circumferentially about the two fingers 1722 a, 1722 b. In aspecific example of this, the cylindrical/tubular section comprise metaland the continuous metallic cylinder that connects the first and secondfingers 1722 a and 1722 b functions substantially like a spring. Inother examples, the slot 1729 may extend substantially along the lengthof the valve 1716 until the proximal portion 1720. An additionalcomponent may be used at the proximal portion 1720 of the valve 1716such as a metal ring to secure the two fingers 1722 a, 1722 b.

In some embodiments of the present invention, the valve 1716 maycomprise a resilient material such as an elastomer, a plastic or ametal. In some embodiments, the valve 1716 may be formed from acombination of resilient and non-resilient materials. As an example ofthis, the valve 1716 has resilient fingers 1722 a, 1722 b that arecoupled to a rigid metallic ring 1721 along the proximal portion 1720.The combination allows the resilient fingers 1722 a and 1722 b to flex,widening slot 1729 to allow passage of material/object there-through ina first direction. The rigid ring 1721 allows the fingers 1722 a and1722 b to close thereafter to prevent the passage of the material/objectthere-through in a second direction. In an alternate example, thefingers 1722 a and 1722 b may comprise a rigid material and the proximalportion 1720 of the valve 1716 may comprise a resilient material. Theproximal portion 1720 then functions to allow the fingers 1722 a and1722 b to open to allow forward passage of material/object through thevalve 1716 and to close thereafter substantially back to their restingposition to prevent backward flow of the material/object there-through.

In operation the device 100 is positioned such that the valve 1716 ispositioned on a distal side of the tissue. A suture passing member maythen be used to pass a portion of the suture 240, such as a knot 250,from the device proximal portion to the device distal tip 12. In onespecific example, the suture passing member comprises a stylet 319 thatmay be housed within the device proximal portion 14. In operation, thestylet 319 is advanced through a first segment of tissue and thenadvanced further through the valve 1716. The valve 1716 expands or opensup to allow the stylet 319 to push the knot through the valve 1716 (FIG.15b ). In other words a distal opening formed at the distal end of thevalve enlarges as the stylet 319 is passed through. In one example, theentire body of the valve 1716 may flex to allow the stylet 319 to pushthe knot therethrough. As the stylet 319 is then retracted, the valve1716 springs back substantially to its closed position as shown in FIG.15c . The distal opening at the distal end of the valve closes back orin other words returns substantially back to its nominal size, thuspreventing the knot 250 and suture 240 from translating proximallythrough the valve 1716. The nominal size is relative in scale to thesize of the knot 250 and is substantially smaller that the knot 250 toprevent the knot from travelling proximally through the valve 1716.

The device 100 may then be repositioned or rotated such that a secondsegment of tissue is positioned within the tissue receiving gap 10. Thevalve 1716 may then be retrieved through the second segment of tissuethat is on an opposing side of the defect using any of the embodimentsas described herein above.

In another example as shown in FIGS. 18a-18c , a device 100 is shown forpassing suture 240 through a region of tissue. The device comprises asuture holder 316 comprising a trap 1816 coupled to the device distaltip 12, the trap 1816 comprising a suture retaining component forreceiving and retaining a portion of a suture 240. The portion of thesuture 240 is passed from a proximal portion 14 of the device throughthe tissue to the device distal tip 12 using a suture passing membersuch as a stylet 519. The stylet 519 may be housed within the needle 116within the device proximal portion. In one particular example the stylet519 may be housed within an additional elongate member 519′ within thehollow needle 116. The stylet 519 may be advanceable from the deviceproximal portion to the distal tip 12 with the elongate member 519′. Thestylet 519 comprises a distal tip 520 for passing the suture portion andpushing it into the trap 1816. In some embodiments, the distal tip 520of the stylet 519 has a sharpened tip or end 521 for carrying the sutureportion. In a specific example of this, the stylet 519 is a barbedstylet additionally having one or more teeth 522 for engaging andcarrying the suture portion. The sharpened end 521 and teeth 522 of thedistal tip 520 allow the suture knot 250 to be translated from thedevice proximal portion 14 through the tissue (at a first location) tobe deposited at the trap 1816 at the device distal tip 12. In someembodiments, the knot 250 may be removably secured to the stylet 319. Inthis particular example, the knot 250 is removably secured to the stylet519 by spearing it using the sharpened end 521 of the stylet 519. Theknot 250 may be passed from a proximal side of the tissue to a distalside of the tissue and may be held at the device distal tip 12 (FIG. 18b) by a suture retaining means such as suture retaining component of thetrap 1816. In one example, the suture retaining component may comprise afinger 1822 within the trap 1816 which can flex to allow the stylet 519to pass the knot 250 through the trap 1816. The finger 1822 subsequentlyreturns to its nominal position when the stylet 519 is retracted, totrap and retain the knot 250 within the trap 1816 (FIG. 18c ). The trap1816 may then be retracted through tissue (at a second locationdifferent from the first location) and passed from the distal side ofthe tissue to the proximal side of the tissue. The trap 1816 may beretracted using a suture holder retrieving member of any of theembodiments described hereinabove to pass the suture 240 through thesecond tissue location. Once the suture 240 has been passed through thefirst and second tissue locations, the opposing free ends of the suturemay be brought together and a closure knot may be provided to secure thetwo ends in place in order to approximate the defect.

In an alternate embodiment of the present invention a device 100 isdisclosed as shown in FIG. 19A. Similar to embodiments described hereinabove, the device 100 has a shaft 16 that is coupled to a distal tip 12via a longitudinally extending neck 15. The shaft 16 is a part of thedevice proximal portion 14. A tissue receiving gap 10 is formed betweenthe distal tip 12 and the proximal portion 14. The distal tip 12 definesa chamber 12B for receiving a suture holder 316. Initially, the sutureholder 316 is housed within the chamber 12B. The distal tip 12 defines aslot 1940. In one particular example, the slot 1940 within the distaltip 12 is an L-shaped slot that is axially and circumferentiallydisposed along an outer surface thereof. The L-shaped slot 1940comprises a substantially rectangular slot 1940 a that is longitudinallyor axially disposed along the exterior of the distal tip 12. Therectangular slot 1940 a is in communication with a substantially squareslot 1940 b which is disposed circumferentially along the exterior ofthe distal tip 12. In one particular example the suture holder 316comprises a trap 1916 having two or more fingers 1922. In other examplesa suture holder 316 may be of the type described in embodimentsdiscussed previously herein. The trap 1916 also defines a substantiallyrectangular slot 1942 that is axially disposed along an outer surface ofthe trap 1916 as shown in FIGS. 19B and 19C. The trap 1916 is positionedsuch that slot 1942 of the trap is positioned substantially adjacentslot 1940 a of the distal tip 12. In other words, rectangular slots 1940a, 1942 are aligned substantially co-axially with respect to each other.As shown in FIG. 19D, a needle 116 is disposed within a proximal portion14 of the shaft 16.

In operation, the device 100 is inserted into a region of tissue at thesite of a defect. The device 100 is positioned such that a first segmentof tissue on one side of the defect is positioned within the tissuereceiving gap 10. The needle 116 is used to carry the suture 240 fromthe device proximal region 14 through the first segment of tissue to thedevice distal tip 12. In one particular example, the needle 116comprises a notch or slot 117 in which the suture strand 240 isdetachably secured, where the suture strand 240 comprises a knot 250 atits distal end. The needle 116 is advanced from the device proximalportion 14 to the distal tip 12. In some embodiments the needle 116 maybe sized to be received within the trap 1916 and may be used to transferthe suture 240 held within notch 117 to be transferred to slots 1940,1942. In other embodiments, the needle 116 carries the suture 240through the first segment of tissue and is advanced further until itabuts the trap 1916. A stylet 319 is housed within the needle 116 and isused to deposit the suture 240 within the distal tip 12. The stylet 319is translated distally until it is received within the trap 1916. Thestylet 319 pushes the knot 250 such that it passes through slots 1940 a,1942 as shown in FIG. 19D. More specifically, the suture 240 ispositioned within slot 117 within the needle 116 such that the knot isplaced outside the needle 116. Slot 117 of the needle 116 is alignedwith slots 1940, 1942 of the distal tip 12 and the suture holderrespectively, such that when the needle 116 is advanced and abutsagainst the trap 1916, the stylet 319 advances the suture 240 into slots1940,1942. Thus, the knot 250 of the suture 240 is carried by the needle116 and then advanced into the trap 1916 and into slots 1940 a, 1942using the stylet 319, such that it rests on the outside of the distaltip 12. The stylet 319 is advanced further until the knot 250 ispositioned at a distal end of each of the slots 1940 a and 1942. Thetrap 1916 is then rotated clockwise for example using the stylet 319 orthe needle 116 (similar to embodiments described herein previously). Amechanism may be provided within the device proximal portion 14 thatthat allows rotation of the needle 116 or the stylet 319. Clockwiserotation of the trap 1916 allows slot 1942 to be translated radially.This allows slot 1942 of the trap 1916 to now be aligned with thesubstantially square slot 1940 b of the distal tip 12, trapping orlocking the knot 250 within slot 1940 b, as shown in FIGS. 19E and 19F.The knot is held within slot 1940 b and rests against/abuts a proximalwall of the slot 1940 b. This prevents knot 250 from translatingproximally. The needle 116 and stylet 319 are then retracted.

The device 100 is then rotated and repositioned such that a secondsegment of tissue is positioned within the tissue receiving gap 10. Theneedle 116 and the stylet 319 are then re-advanced through the secondsegment of tissue until the needle 116 abuts against the trap 1916. Thestylet 319 is then advanced further until the tip of the stylet 319 ispositioned distal to the trap and the stylet 319 engages with the trap1916. The stylet 319 is then rotated counterclockwise to translate slot1942 radially such that it is aligned again with slot 1940 a of thedistal tip 12. The knot 250 not longer abuts the proximal wall of slot1940 b and is free to move proximally within the slots 117,1942, of theneedle and the trap respectively Thus, the stylet 319 is then retractedto withdraw the trap 1916 along with knot 250, as shown in FIG. 19G.This allows suture 240 to be passed through the second segment oftissue. The suture 240 can then be used to approximate the defect.

Embodiments of Devices for Deploying a Suture Knot

In another broad aspect of the present invention, device 100 includesfeatures for deploying a suture knot, such as a partially pre-tiedsuture knot, as illustrated in various embodiments shown in FIG. 21-27.Some embodiments of device 100 comprise a retaining element that iscoupled to the device 100 for retaining a portion of the suture duringat least a part of the knot deployment procedure.

Features for Directly Coupling a Partially Pre-Tied Knot onto the Device

In particular as shown in FIG. 21a , in some embodiments, the devicecomprises an elongate member 110 having a retaining or tensioningelement 900 disposed thereon. In some embodiments, in addition todeploying a suture knot, the device 100 may also be used to pass asuture 240 through a region of tissue 200 prior to deploying the knot.For example, device 100 may be used to pass suture through first andsecond segments, 201, 202 of a region of tissue 200 having a defect 300,as described herein. In other embodiments, another device may be used topass the suture 240 through the region of tissue 200 and device 100 isused to deploy a suture knot.

In the illustrated embodiment, a suture 240 is formed into one or moreloops 700 around the elongate member 110. In one particular example, theretaining or tensioning element 900 may be coupled to the device 100proximal (relative to a user) to a location of the one or more sutureloops 700. A first portion 701 of the suture 240 extending from the oneor more loops 700 is coupled to a distal end of the device 100. In oneparticular example, the first portion 701 defines a post 703. Segment703 a of the post 703 generally extends from the tissue 200,specifically segment 202 of the tissue, to the device 100 where it iscoupled. Whereas, segment 703 b extends from the tissue 200,specifically segment 201 of the tissue 200, to the loops 700 of thesuture 240. During use, the lengths of each of the segments 703 a, 703 bmay vary at various points during the procedure. A second portion 702 ofthe suture 240 extends from the one or more loops 700 and interacts withthe retaining or tensioning element 900, the second portion 702 beingsubstantially longitudinally opposed (i.e. if the suture were to bereleased from the device and, for example, straightened out, portion 702would be substantially longitudinally opposed to portion 701) to thefirst portion 701. In one specific example, the second portion 702 ofthe suture 240 forms a locker 704. In one specific example, the secondportion 702 is passed under the retaining or tensioning element 900 andis held in frictional engagement between the retaining or tensioningelement 900 and the elongate member 110. In other embodiments, thesuture 240 may be routed and retained in other ways through theretaining or tensioning element 900. In alternate embodiments shown inFIGS. 24 and 26, the loops 700 of the partially pre-tied knot may beformed onto a portion of the shaft 16.

Alternative Embodiment of a Device for Deploying a Knot, the DeviceComprising a Retaining or Tensioning Element in the Form of a ResilientSpring Member

In an alternate embodiment the retaining or tensioning element maycomprise a resilient spring member 912 as shown in FIG. 24. The device100 is illustrated after loops 700 of the pre-tied knot have beendeployed from the device 100 onto the post 703 of the suture 240 forminga Dines knot 720 as the post 703 is pulled through the loops 700.Similar to embodiments discussed previously, the first portion 701 ofthe suture 240 forms the post 703 and the second portion 702 of thesuture 240 forms the locker 704 with the post comprising segments 703 aand 703 b. The locker 704 is held in tension by the resilient springmember 912 that is coupled to the device 100. In one specific example,the resilient spring member 912 may be hook-shaped. The locker maybeformed into a loop Y, and the loop Y may held in engagement by theresilient hook-shaped member 912 that passes through the loop Y.

In an alternate embodiment, the retaining or tensioning element 900 forholding the second portion 702 of the suture such as the locker 704, mayinclude interlocking mechanical pieces. In one example the retaining ortensioning element 900 may comprise two interlocking mechanical pieces,whereby a first mechanical piece is coupled to the locker 704 andmaintains tension on it. In other words, the retaining or tensioningelement 900 provides resistance against the movement of the locker 704.The retaining or tensioning element may provide a frictional forceagainst the locker 704. The first mechanical piece interacts with thesecond mechanical piece (i.e. the two pieces are co-operatively engagedwith each other).

Features for Indirectly Coupling a Partially Pre-Tied Knot on the Device

Features outlined herein below will be described with respect to adevice 100 is disclosed as shown in FIG. 22a which of the type describedhereinabove with respect to FIGS. 1, 4-6. The device 100 has a shaft 16that is coupled to a distal tip 12 via a longitudinally extending neck15. The shaft 16 is a part of the device proximal portion 14. A tissuereceiving gap 10 is formed between the distal tip 12 and the shaft 16. Aneedle 116 is housed within the device proximal region 14 and oneportion of a suture or a suture strand 240 is coupled to the device 100,for example to the needle 116. In some embodiments, the suture 240 maybe secured within the needle 116 for example in proximity to the needletip. In a specific example of this, the suture 240 may be formed into aknot and retained within a slot within the needle tip.

The suture 240 may be formed/arranged into one or more loops 700 wrappedaround a portion of the shaft 16. In other words the suture 240 may beformed into a partial or fully pre-tied knot. In one broad aspect,embodiments of the present invention provide a means is provided forindirectly coupling the loops 700 of the partially or fully pre-tiedknot onto the device 100. In other words, a partially or fully pre-tiedknot is provided without coupling or tying the loops 700 of thepartially pre-tied knot directly onto the device 100. In one suchexample, as shown in FIGS. 22a-22g the one or more loops 700 of thepartially or fully pre-tied knot are formed around a knot slider 800that is mounted on the shaft 16 and detachably coupled thereto. In onespecific example, the loops 700 are wrapped around the exterior of theknot slider proximal to a flexible arm 818 of the knot slider 800. Thearm 818 is shown in its initial position in FIGS. 22c and 22d (iii). Inits first position 818A, the arm 818 prevents the loops 700 from slidingoff the knot slider 800 and thus serves as an obstructing member 818.

With respect to FIG. 22c , the suture 240 exits the needle 116, extendsproximally and forms a service loop L. The suture 240 is then arrangedinto the one or more loops 700 around a portion of the knot slider 800.The portion of the suture 240 coupled to the needle 116 distal to theloops 700 may be termed a first portion 701 of the suture 240. Asubstantially longitudinally opposed second portion 702 of the suture240 extends proximally from the suture loops 700. In one specificexample, the second portion 702 of the suture 240 forms a locker, orknot locker. In one specific example the first portion 701 of the suturedefines a post.

In a specific example, as shown in FIG. 22d (i) the knot slider 800comprises an inner slider body 802 and an outer slider body (or externalknot slider) 804. The inner slider body 802 comprises a substantiallycylindrical projection 806. The projection 806 defines a lumen 810 and adistal opening 812. A longitudinally extending slot 814 runssubstantially along the length of the projection 806 and is incommunication with distal opening 812 and lumen 810. Additionally, apartially circular slot 816 is formed into the inner slider body 802 atthe base of the projection 806 and partially surrounds projection 806 asshown in FIG. 22d (ii), showing a rear view of the knot slider 800. Aboundary or edge 817 defines the slot 816. The slot 816 is incommunication with slot 814 as well the device lumen 810 also shown inFIG. 22d (iii), showing a rear perspective view of the knot slider 800.In some embodiments, a retaining or tensioning element is mounted ontothe projection 806. In some examples the retaining or tensioning elementcomprises a resilient material such as an O-ring (an “elastomeric ring”)or a short section of tubing. In the particular embodiment shown inFIGS. 22a-22h , the retaining or tensioning element comprises an O-ring910. In one particular example, a retention force applied by the O-ring910 may comprise the force of friction. In some embodiments theretention force may be varied by changing the normal force and bychanging the coefficient of friction (which may be altered by changingmaterial properties or surface roughness).

As mentioned previously, the loops 700 are formed onto the knot slider800, and the first and second portions 701, 702 of the suture 240 extendfrom the loops 700, as shown in FIG. 22c . In some embodiments a segmentof the second portion 702 of the suture 240 may be restrained orsubstantially held in place by the retaining or tensioning element (suchas the O-ring 910). In other embodiments the retaining or tensioningelement, (such as the O-ring 910) may be used to secure both the firstand second portions, 701, 702 of the suture 240. In the exemplaryembodiment, shown in FIGS. 22d (i)-(iii), the second portion 702 ofsuture 240 is passed through an opening 805 within the external knotslider 804 and into the opening 812 formed within the projection 806 ofthe inner slider body 802. The suture 240 is then passed through lumen810 of the projection 806. In order to secure the suture portion 702using the O-ring, the suture 240 may then be guided in the direction Galong slot 816 as shown in FIG. 22d (iv) such that it is held by theO-ring 910 and is pinched between the projection 806 and the O-ring 910.

This is further illustrated in FIG. 22e , where the suture 240 is guidedlaterally outwards (as shown by directional arrow A) such that it exitsfrom the longitudinally extending slot 814). The suture 240 may then beguided in a circular motion (as shown by directional arrow B) throughthe slot 816 such that it is positioned between the projection 806 andthe O-ring 910. The resilient O-ring 910 substantially holds orrestrains the second portion 702 of the suture 240 by applying a forceto maintain tension on it. Specifically, the O-ring functions tomaintain tension on the second portion 702 of the suture by frictionallyengaging it. In addition to holding the second portion 702, the sutureretaining element such as O-ring 910 can hold one or more other portionsof the suture 240, such as the service loop L of the suture firstportion 701. In one such example, the service loop L of the firstportion 701 may be passed through the O-ring together with the secondportion 702 in the manner described above. Once passed through theO-ring, both the service loop L of the first portion 701 and the secondportion 702 may be routed through the device proximal portion 14, forexample through tubing as shown in FIG. 22f . In one such example, theO-ring functions to keep the service loop L taut to allow one end ofsuture portion 701 to remain coupled to the needle 116 housed within thedevice shaft 16. In a specific example, the suture portion 701 iscoupled to the needle tip via a knot formed at the end of the sutureportion 701. The O-ring helps to keep the suture portion 701 taut toretain the knot within a slot within the needle tip.

Features for Controlled Deployment of a Partially Pre-Tied Knot

In one broad, embodiments of the present invention provide a means toallow for a controlled deployment of a partially or fully pre-tied knot.As a feature of this broad aspect, a knot slider is provided that iscoupled to the shaft/handle of the device via a releasable coupling. Asa further feature of this broad aspect, a means is provided to preventthe partially or fully pre-tied knot from sliding until a predeterminedforce is applied to the releasable coupling.

Feature for Releasably Coupling Knot Slider

Detachable Coupling Using a Projection on the Arm

In one specific example, the shaft 16 of the proximal portion 14comprises a notch or a recess 1601, as shown in FIG. 22j , whichco-operatively engages with a projection 820 on the knot slider 800. Inone example, a projection 820 is formed on the flexible arm 818 of theouter slider body 804, which co-operatively engages with recess 1601 inorder to detachably couple the knot slider 800 to the shaft 16. In someembodiments, the projection 820 may be formed at any other suitablelocation on the knot slider 800. In other embodiments, a projection maybe formed on the shaft 16 that may engage a recess within the knotslider 800. Alternatively, any other engagement mechanism may beprovided that allows the knot slider 800 to be detachably coupled to thedevice 100.

Detachable Coupling Using Projections on the Slider and Device ProximalPortion

In one specific example, as shown in FIGS. 22i and 22j , the projection820′ may be formed within a portion 822 of the outer slider body 804that defines a hollow cavity 823. Portion 822 of the knot slider 800 isthen mounted onto a raised segment 1401 of the device proximal portion14. In other words, the raised segment 1401 of the device proximalportion 14 is received within the hollow cavity 823 defined by the knotslider 800. In one example, the raised segment 1401 is formed onto ahandle body forming a part of the device proximal portion 14. Anadditional projection 1402 is formed on the raised portion 1401. Whenthe knot slider 800 is mounted onto the raised portion 1401, theprojection 1402 of the device proximal portion and projection 820′ ofthe knot slider form a snap-fit engagement for detachably coupling theslider 800 to the device proximal portion 14. This may help ensure thatthe knot slider 800 remains in its proximal position during shipmentand/or handling of the device and during use, until such as time as isdesired for the knot slider 800 to be released from its proximalposition.

Passive Coupling Between the Knot Slider and the Device Proximal Portion

In one specific example as shown in FIG. 22k , the knot slider 800 ispassively coupled to the shaft 16 of the device 100. The O-ring 910 ismounted onto the projection 806 and an additional projection 806′, asshown. The shaft 16 presses into O-ring to deflect the O-ring. Thus,there is contact between the O-ring and the shaft 16. The knot slider800 is passively coupled to shaft 16 via interference or frictionalengagement between the O-ring 910 and shaft 16. The frictionalengagement between the O-ring and shaft 16 is sufficient to preventpremature deployment or disengagement of the knot slider 800 from theshaft 16.

Features for Deploying a Partially Pre-Tied Knot Distal to the Device

In another broad aspect, embodiments of the present invention providefeatures for deploying a partially pre-tied knot distally off of thedevice. As a feature of this broad aspect, embodiments of the presentinvention provide a means to prevent loops of the partially pre-tiedknot from getting caught within the device (for example within a tissuereceiving gap of the device) prior to deployment. As an example of thisfeature, a knot slider is provided that is detachably coupled to thedevice that slides to a distal position to cover the tissue-receivinggap, with the loops being released once the gap is covered to preventthe loops from being engaged within the gap. The knot slider preventsthe loops from sliding off until it is in its distal position over thegap at which point the knot slider allows the loops to be deployed orreleased. In one particular example, the knot slider has a flexible armthat blocks/prevents the loops from sliding off until the slider is inits distal position over the tissue receiving gap, at which point thearm can bend into the tissue receiving gap allowing the loops to slideoff the knot slider. In a further example, the arm and the knot sliderhave tapers to facilitate sliding of the suture.

Stopping Mechanism for Positioning Knot Slider in its Distal Position

Stopping Mechanism Comprises a Tail Hook on the Knot Slider

As the knot slider 800 translates distally along the shaft 16, astopping mechanism may be provided to allow the knot slider 800 to bepositioned over the tissue receiving gap 10. In this distal position,Since, the knot slider 800 covers the tissue receiving gap 10 in thisdistal position, it prevents the loops 700 from being released withinthe tissue receiving gap 10 and getting stuck therein. In oneembodiment, the knot slider 800 comprises a tail hook 824. In a specificexample, the tail hook 824 is a part of the inner slider body 802. Thetail hook 824 is operable to slide along a recess or groove 1603 thatruns along a portion of the shaft 16, as shown in FIG. 23b (i). When thetail hook 824 reaches the end of the recess or groove 1603, furtherdistal translation of the knot slider 800 is impeded. The tail hook 824abuts against or engages a portion of the shaft 16, allowing the knotslider 800 be positioned in its distal position over the tissuereceiving gap 10. The tail hook 824 stops the knot slider 800 in thecorrect position so the flexible arm 818 is lined up with/adjacent thetissue gap 10, so that it can be deflected into the tissue receiving gap10 when tension is applied to the suture 240, to allow the loops 700 tobe released. Furthermore, the tail hook 824 may additionally prevent theknot slider 800 from falling off the shaft 16.

Stopping Mechanism Comprises a Snap

In other embodiments, alternative means of stopping distal translationof the knot slider may be provided. In one example, a snap or snap armmay be provided instead of a tail hook to allow the knot slider 800 tostop in the desired distal position. The snap may be actively biasedtowards the shaft and may comprise an engaging feature that clips orgrabs onto the shaft with a biasing force. As the knot slider 800translates distally along the shaft, the snap rides along the shaftuntil it reaches the tissue receiving gap and is deflected therein (orsnaps into the tissue gap) because of the bias. As a result, the snapabuts/stops against the proximal face of the distal tip 12. In oneparticular example, two snaps or snap arms may be provided to mitigatethe risk of one of the snaps interfering with the taut segment 703 a ofsuture portion 701 that is running across the tissue receiving gap 10.This allows at least one of the snaps to be deflected into the tissuereceiving gap 10 to stop the knot slider 800 in its desired distalposition.

Features Allowing Loops to be Released

A Deflectable Flexible Arm

As described hereinabove, the loops 700 are held in place by the arm 818which prevents them from sliding off. The flexible arm 818 has beenpositioned against and rests against the shaft 16 until the knot slider800 is in its distal position. During the time that the arm 818 is inits initial position 818A, it cannot bend inwards due to hindrancecreated by the shaft 16. However, when the knot slider is in its distalposition, the inward motion of the flexible arm 818 is no longer blockedby the shaft 16, as the flexible arm 818 is now positioned adjacent thetissue receiving gap 10. Therefore, as the device 100 is pulled,continued tension on the suture 240 causes the flexible arm 818 to bendor deflect inwards into the tissue receiving gap 10 into its second orbent position 818B, as shown in FIG. 23b (ii). The loops 700 are nolonger substantially blocked by the arm 818 and are free to slidedistally off the arm 818. In one example as shown, the arm 818 of theknot slider 800 is angled or tapered, which facilitates the removal ofthe loops 700 by allowing them to slide along the tapered surfaces ofthe arm 818. In a specific example, as shown, the arm 818 is ofsubstantially a triangular shape comprising both a distal taper and aproximal taper. In some embodiments, the arm 818 may be actively biasedand once the arm 818 is located adjacent the tissue receiving gap 10, inthe absence of any obstruction/hindrance created by the shaft 16, thearm 818 moves inwards towards its biased position such that it ispositioned within the tissue receiving gap 10. In some embodiments, asthe arm 818 may be sized to allow the arm to deflect into its secondposition distal to the device distal tip 12. In other words, instead ofthe arm 818 being deflected into the tissue receiving gap 10, the arm818 is deflected into the space distal to the device 100. In someembodiments, an automatic mechanism may be provided for the release ofthe loops 700. In one such example, the loops 700 may be released whenthe user presses a button. Alternatively, in some embodiments, the loops700 may be released by an additional squeeze of a trigger, such as athird squeeze of the trigger.

Taper on the Knot Slider

Additionally, in some embodiments, the knot slider 800 along a portionthereof is also angled and tapers down towards its distal end, In otherwords, the knot slider 800 reduces in diameter from its proximal end toits distal end. In some embodiments, the knot slider 800 may comprise adownward step between tapered portions thereof. Since, the loops 700 arewrapped around the knot slider 800 and thus constrict around it, thedownward taper of the knot slider 800 may allow the loops 700 to bereleased/slide off with relative ease. Furthermore, the downward taperof the knot slider 800 may prevent the loops 700 from getting caught on(or gripping/binding to) the knot slider 800 and thus may allow theloops 700 to be released. In some embodiments, the distal direction isdefined as the direction along the longitudinal axis of the device 100away from the user, and the proximal direction is defined as thedirection along the longitudinal axis of the device towards the user.Additionally the top of the knot slider 800 is defined as the side ofthe knot slider 800 where the arm 818 is positioned, whereas the bottomof the knot slider 800 is defined as the opposing side. In someembodiments, when the loops are installed on the knot slider 800, theloops 700 may not be vertical/perpendicular with respect to the shaft 16when viewed from the side, as shown in FIG. 23a . The loops 700 may beoriented at an angle from the vertical or perpendicular as shown. Thebottom portion of the loops is defined as the portion of the loops 700that is in contact with the bottom of the knot slider 800 and the topportion of the loops is defined as the portion of the loops 700 incontact with the top portion of the knot slider 800. In someembodiments, if the bottom portion of the loops 700 is positionedproximally to the top portion; as tension is applied to the loops 700 torelease the loops 700, the top portion starts to move and the loops maygrip/bind on the knot slider 800 and not come off. Thus, in someembodiments, the loops 700 may be oriented such that the portion of thebottom portion of the loops 700 at the bottom of the knot slider 800 ispositioned distal to the top portion of the loops 700 at the top of theknot slider 800.

Alternatives

Needle Spanning the Tissue Receiving Gap

In some embodiments, means may be provided to allow the needle 116 tospan across the tissue receiving gap 10, prior to deploying thepartially pre-tied knot. In one particular example, the device 100 iswithdrawn to deploy the partially pre-tied knot. As the device 100 iswithdrawn, the suture loops 700 of the pre-tied knot first slidedistally along shaft 16, and then along the needle 116 spanning acrossthe tissue receiving gap 10. The loops 700 then may slide onto thedistal tip 12 and are subsequently released distal to the device 100.Additional features may be provided to facilitate translation of thesuture loops 700 at the transition between the needle 116 and the distaltip 12.

Tubing to Cover the Tissue Receiving Gap

In some embodiments, the device 100 may be provided with a sheath ortubing that is positioned around the shaft 16. Prior to deploying thepartially pre-tied knot, the sheath or tubing may be advanced such thatit spans across or covers the tissue receiving gap 10. Similar toembodiments discussed above, in one particular example, the device maybe withdrawn to release/deploy the loops 700 of the partially pre-tiedknot. The loops 700 of may slide distally along the shaft 16 until theyreach the sheath or tubing spanning across the tissue receiving gap 10.The loops 700 may then slide along the sheath or tubing and onto thedistal tip 12. The loops 700 may then be released distal to the devicedistal tip 12. In one specific example, the sheath or tubing maycomprise clear tubing.

Manipulating the Device Distal Tip

Retracting the Device Distal Tip

In some embodiments, the distal tip 12 of the device 100 may beretracted to close the tissue receiving gap 10, to enable the loops 700of the partially pre-tied knot to be released without being caughtwithin the tissue receiving gap 10. Thus, in one example, when thedevice 100 is retracted to release the loops 700, the loops 700 mayslide distally along the shaft 16 and then along the distal tip 12 thathas eliminated/closed the tissue receiving gap 10. The loops may then bereleased distal to the device distal tip 12.

Swivel the Device Distal Tip

In alternate embodiments, the distal tip 12 of the device 100 may bepivotally coupled to the shaft 16 and may be pivoted or swiveled withrespect to the shaft 16, prior to deploying/releasing the pre-tied knot.Thus, the distal tip 12 may be pivoted (or rotated) away from the pathof the loops 700. The loops 700 may then be released and may slidedistally along the shaft 16 without being caught within the tissuereceiving gap 10.

Each of these embodiments are described in greater detail hereinbelowwith reference to the device in use.

In some embodiments, a device 100 may be provided for passing suturethat contains features for managing suture as described herein belowwither reference to FIGS. 28a-h and FIGS. 29a -e.

Features for Suture Management

In one broad aspect, the device of the present invention comprisesfeatures for suture management. By means of introduction, certainfeatures have been incorporated into the device for preventing damage tothe suture, while other features have been incorporated into the devicefor routing the suture. Still furthermore, features are provided toprevent the device from jamming.

In some embodiments, the present invention provides a structure/featureto allow suture to be routed without being constrained. As an example ofthis, embodiments of the present invention provide a slot.

In some embodiments, the present invention provides a means to limitdamage to the suture while the suture is being manipulated. As anexample of this, embodiments of the present invention provide aspacing/gap to allow suture to pass freely without fraying. In anotherexample, embodiments of the present invention provide surfacemodifications such as cut-outs to prevent damage to the suture such asfraying.

In some embodiments, the present invention provides a means to preventthe device from jamming or locking. As an example of this, embodimentsof the present invention provide a spacing/gap for the suture to preventthe suture from binding the device mechanism. In another example,embodiments of the present invention provide surface modifications suchas cut-outs to provide space for the suture to prevent the suture frombinding the device mechanism.

Example 1

The various features described above will be discussed with reference tousage of the device as shown in FIGS. 28a-28h . Certain features of thedevice related to suture management may be described with respect to oneor more stages of a medical procedure (i.e. the same features may bediscussed more than once, if they play a role at more than one stage ofthe procedure).

A device 100 is disclosed for passing a suture 240 through a region oftissue. Device 100 comprises a device proximal portion 14 comprising ashaft 16 that is coupled to a device distal tip portion having a distaltip 12. The device 100 further comprises a suture moving assembly 2822housed within the device 100 for moving a suture 240 between the deviceproximal portion 14 and the distal tip 12. The suture moving assembly2822 comprises a needle 116 within which a stylet 2819 is positioned.The stylet 2819 and the needle 116 are housed within chamber or channel16B defined by the shaft 16. A suture 240 (comprising an enlargedportion such as a knot 250) is held at one end within the needle 116,with the knot 250 being retained within the needle and the stylet 2819being positioned proximal to the knot 250.

Features Used, for Example, During Initial Passing of Suture DistallyThrough Tissue

Features for Facilitating Routing of the Suture

In some embodiments, the device 100 described comprises astructure/feature to allow the suture 240 to be routed in a mannerlimiting constraint of the suture. In one specific example, the featurefor facilitating routing of the suture 240 comprises a slot. The suture240 is guided through a slot 2817 to the exterior of the needle andexists through as similar slot 2817′ formed within the shaft 16 as shownin FIG. 28b . The needle slot 2817 and the shaft slot 2817′ are 90degrees out of rotation with respect to each other as shown in FIGS. 28aand 28b . In other words, the needle slot 2817 and the shaft slot 2817′are radially offset from one another. The enlarged portion of the suture240, such as a knot 250 is unable to pass through the slot 2817 withinthe needle, thus maintaining the position of the enlarged portion of thesuture within the needle lumen. The slot 2817 within the needle may bepositioned proximal and, for example, adjacent to, a distal end of theneedle 116.

In one example, slots 2817 and 2817′ are designed to route the suture240 towards the exterior of the shaft 16, so that the suture 240 doesnot interfere with forward translation of the suture moving assembly2822 thus substantially minimizing damage to the suture 240. Thus, inthe specific embodiment shown, the risk of suture 240 getting frayed orchaffed is substantially reduced as the needle/stylet assembly isadvanced distally to pass the suture 240 through a segment of tissue(positioned within tissue receiving gap 2810) and into the sutureholder. In some embodiments, the slot 2817 is provided with a bluntface, which may further minimize the risk of damage to suture 240 as itis routed through the slot. Furthermore, the slot 2817 also may helpprevent damage to the suture 240 by preventing the suture 240 from beingrouted across a sharp end point of the needle 116. Additionally, theslot 2817 minimizes damage to the suture 240 resulting from pinchingwhich prevents the device 100 from jamming or locking. Slot 2817′ of theshaft 16 works in conjunction with the needle slot 2817 to perform asimilar function including reducing the risk of device failure due tobinding/locking of the device. In some embodiments as shown in FIG. 28a, the suture may be held in frictional contact between the stylet 319and needle 116.

In some embodiments, the slot 2817 may offer additional advantages. Inone specific example, since the suture 240 is located in the slot 2817behind a bevel end face of the needle 116, the slot 2817 of the needleallows tension to be applied to the suture 240 while enabling the knot250 to remain within the needle (when it is pulled against the innerwall of the needle 116). In the absence of a slot 2817, the suture 240may exit the needle 116 as tension is applied to the suture 240. Inother words, in the absence of the slot 2817, tension may cause thesuture 240 to be pulled out of the needle 116. Thus, the needle slot2817 allows the suture 240 to be maintained within the needle slot 2817such that the suture position remains substantially fixed relative tothe needle 116 when the needle 116 is advanced towards the trap 2816(i.e. during deployment). In such embodiments, the suture, whileretained within needle 116, may or may not be substantially coupleddirectly thereto. This may additionally help minimize the risk of suture240 getting damaged or interfering with the suture moving assembly (i.e.locking/binding the device mechanism) as it is advanced.

In some alternative embodiments, a slot is present only in the shaft andnot in the needle or vice versa.

Gap or Spacing for Suture Management

In order to pass the suture 240 through the tissue, the device 100 ispositioned such that a first segment of tissue is received within thetissue receiving gap. The suture moving assembly 2822 (comprising needle116, stylet 2819 and suture 240 operably coupled thereto) is thentranslated distally, such that it passes through the first segment oftissue until the needle 116 abuts a suture holder such as the trap 2816,as illustrated in FIG. 28c . The stylet 2819 is then advanced further todeposit the suture knot 250 and thus suture 240 within the trap 2816 asshown in FIG. 28d , whereas the needle 116 cannot be advanced furtherdue to interference by the trap 2816. The trap 2816 may comprisefeatures, as described previously, to capture the suture 240. The stylet2819 is now positioned within the trap 2816.

Gap or Spacing Provided Between the Needle Distal End Face and the TrapProximal End Face

In one specific example, as shown in FIGS. 28c and 28d , a gap orspacing 2834 is provided between the distal end face of the needle andthe proximal end face of the trap for suture clearance. The suture 240is routed through the gap or spacing 2834 substantially without beingdamaged or frayed. In other words, as the stylet 2819 is advanced, thesuture 240 is translating relative to the needle 116 and the trap 2816.By having a gap or spacing 2834 between needle 116 and trap 2816, thesuture 240 is substantially free to move.

In one specific example as shown, the gap or spacing 2834 is created byproviding a mismatch between the distal end face of the needle 116 andthe proximal end face of the trap 2816, as shown in FIGS. 28c and 28d .More specifically, the gap or spacing 2834 is created by providingdiverging angles on the trap face and needle face. In one example, achamfer is additionally provided on the trap edge. In one specificexample, the gap or spacing 2834 is created by providing a reliefcut-out 2830 r. The relief cut-out 2830 r provides a passage between thetrap 2816 and the needle 116, and prevents the suture 240 from gettingfrayed or chaffed due to suture 240 being pinched between the trap 2816and the needle 116 as shown in FIGS. 28d and 28f . Thus, the reliefcut-out 2830 r helps minimize damage to the suture 240. By minimizingthe risk of suture 240 being pinched the relief cut-out may also preventthe device 100 from getting locked/jammed.

Advantages of the Gap/Spacing in Preventing Damage to Suture

As shown in FIGS. 28c and 28d , the gap or spacing 2834 formed betweenthe distal end face of the needle 116 and the proximal end face of thetrap 2816, provides sufficient clearance to prevent suture 240 frombecoming pinched between the needle 116 and the trap 2816, which mayhelp prevent chafing or fraying or severing of the suture 240.

Advantages of the Gap/Spacing in Preventing Binding/Jamming of theDevice

Additionally, the gap or spacing 2834 prevents jamming/locking of thedevice by preventing pinching of the suture 240. In other words, in someembodiments, the gap or spacing 2834 allows for improved routing ofsuture 240 which may substantially reduce the risk of failure of device100. More specifically, the gap or spacing 2834 between the needle 116and the trap 2816 may help prevent the suture moving assembly 2822(which includes the needle 116 and the stylet 2819) or any of the movingcomponents within device 100 from binding or jamming due to the suture240 getting caught therebetween.

Gap or Spacing Provided Between the Stylet and the Trap

Furthermore, the suture moving assembly 2822 (or a part thereof) mayalso comprise features to substantially minimize damage to the suture240. In one specific example, as illustrated in FIGS. 28c-28d , thestylet 2819 has a reduced cross-section along a distal portion thereof(also discussed previously and shown in FIGS. 7a-7e ). When the stylet2819 is positioned within the trap 2816 to deposit the suture 240 withinthe trap 2816, a gap or spacing 2836 forms between the distal portion ofthe stylet 2819 having the reduced cross-section and an inner wall ofthe trap 2816. In other words there is a clearance for the suture 240adjacent to the stylet 2819. In some embodiments, the gap or space 2836may be provided in the form of symmetric clearance as shown in FIG. 28d(ii) where the stylet 2819 has a reduced cross-section substantiallyalong its outer periphery. In other embodiments, the gap or spacing 2836may be provided in the form an asymmetric clearance as shown in FIG. 28d(i), where a portion of the stylet 2819 periphery has a reducedcross-section.

Advantages of the Gap/Spacing

In operation, as the stylet 2819 translates out of the needle 116 andinto the trap 2816, the suture 240 is advanced with it as the knot 250is pushed by the stylet 2819. Having clearance or gap/spacing 2836substantially adjacent to the stylet 2819 allows the suture 240 to slideinside the trap 2816 without pinching or binding and allows the stylet2819 to deposit the suture knot 250 within the trap 2816 such that it iscoupled thereto. In other words, the gap or spacing 2836 allows thesuture 240 to travel. Thus, the gap or spacing 2836 substantiallyprevents fraying of the suture 240 as it is routed between the trap 2816and the stylet 2819 as the stylet 2819 is advanced. Furthermore, the gapor spacing 2836 also prevents the device from jamming by preventing thesuture from being pinched or caught between the stylet 2819 and the trap2816. The stylet 2819 is then withdrawn from the distal tip 12 to theshaft 16. The clearance of gap/spacing 2836 may also aid withdrawal ofthe stylet 2819, by preventing damage to the suture 240 and bypreventing jamming of the device as the stylet 2819 is withdrawn. In onespecific example, a minimal amount of clearance is provided between thetrap 2816 and the interior of the distal tip 12, sufficient to providethe advantages described above while minimizing the risk of suture 240being caught between trap 2816 and the interior of distal tip 12.

Surface Modifications for Suture Management

After, the stylet 3019 has been withdrawn from the distal tip 12 to theshaft 16, the device 100 is re-positioned to pass suture 240 through asecond segment of tissue. As shown in FIG. 28e , as the device 100 isrotated for example by 180 degrees, the suture 240 is pulled towards theaxis of rotation of the device, for example, along the longitudinallyextending neck 15 of the device 100. In some embodiments, as discussedpreviously, in order to prevent the suture 240 from being caught andfrom chafing, a relief cut-out 2830 r (this feature is more clearlyillustrated in FIG. 28e ) is provided within the trap 2816 of the suturemoving assembly 3022. In some embodiments, the relief cut-out 2830 r isprovided at the location where suture 240 is pulled and positioned whenleaving the distal tip 12, thus substantially preventing the suture 240from being damaged. More specifically, in some embodiments, the reliefcut-out 2830 r is provided within the trap 2816 towards the rotationalaxis of the device 100, as shown in FIG. 28e . In other words, therelief cut-out 2830 r is provided within the trap 2816 at a locationfacing or adjacent the neck 15, as shown in the drawings, and preventsthe suture 240 from being frayed or cut against a sharp corner or edgeof the trap 2816, as it is routed away from the distal tip 12. Inaddition, cut-out 2830 r allows additional room for suture routing,thereby reducing the risk of the suture causing the device to jam orlock-up.

Features Used During Withdrawal of Suture Proximally Through Tissue

Features in the Distal Portion

Gap or Spacing for Suture Management

Gaps/Spacings Between the Stylet, Needle and the Trap

As shown in FIG. 28f , the stylet 2819 having a stylet tip 2820, is thenre-advanced distally a second time, such that is passes through a secondsegment of tissue towards the distal tip 12. On the second advancementof the stylet 2819, substantially all of the stylet tip 2820 passesthrough the trap 2816 to couple the trap 2816 thereto. The gap or space2836 between the stylet 2819 and trap 2816, as well as gap 2834 betweenneedle end face and trap 2816 (both gaps shown previously) mayadditionally help limit or prevent damage to the suture 240 as thestylet 2819 is advanced. The gap 2834 is further enhanced by the cut-out2830 r, to ensure that the suture 240 is not damaged or constrained asthe needle 116 and the stylet 2819 are advanced. As a result, the riskof the device 100 binding/jamming may be reduced. Additionally, in orderto accommodate the stylet tip 2820 within the trap 2816, the knot 250(and thus suture 240) advances distally with the stylet tip 2820 as thestylet tip 2820 passes through the trap 2816. The gap or space 2836(shown and discussed above) allows the knot 250 and the suture 240 to beadvanced distally substantially without being pinched or bound. The gapor space 2836 may also substantially prevent the suture 240 from beingdamaged minimizing chafing or fraying of suture 240.

Gap or Spacing Formed Distal to the Trap

Additionally as shown in FIG. 28f , a space or gap may be provideddistal to the trap 2816 within the distal tip 12 in order to accommodatethe knot 250. In one specific example, the space or gap may be providedin the form of a channel 2838, which is more readily visualized in FIG.28g . The channel 2838 is provided between the suture moving assembly2822 (i.e. trap 2816 of the suture moving assembly 2822) and a wall ofthe distal tip 12 that defines chamber 12B. The channel is of asufficient length to ensure that the knot 250 can advance a sufficientdistance in front of the stylet 2819. In other words, the channel 2838allows the knot 250 to advance a distance substantially equal to thelength of the stylet tip 2820. The channel 2838 may help prevent theknot 250 from falling to the side of the stylet 2819. The channel 2838allows suture 240 to be drawn distally through the trap 2816, minimizingpinching of the suture 240 by the stylet tip 2820 as it passes throughthe trap 2816. This may help minimize risk of failure of device 100.More specifically, the dimensions of channel 2838 may help preventbinding of the device mechanism as the stylet 2819, trap 2816 and sutureknot 250 are withdrawn back through the distal tip by avoiding suture240 getting caught there-between. The gap or space 2836 between thestylet and trap 3106, as well as gap 2834 between needle end face andtrap 2816 may additionally help prevent damage to the suture as thestylet is withdrawn. Furthermore, the channel 2838 (specifically, thelength thereof) also prevents the stylet 2819 from becominginadvertently coupled to a distal face of the device distal tip 12.

Surface Modification for Suture Management

Additional features may be provided within the device 100 to further aidin minimizing damage to the suture 240 as the trap 2816 and thus sutureknot 250 are withdrawn using the stylet 2819 through the second segmentof tissue towards the proximal portion 14. As shown in FIG. 28g , thesuture 240 bends at about 180 degrees around the trap 2816 as the trap2816 (and thus suture 240) is withdrawn through the second segment oftissue upon retraction of the needle 116 and the stylet 2819. Thus thesuture 240 makes a sharp bend around the face of the trap 2816. A reliefor cut-out may be provided within the trap 2816 such as cut-out 2830 r(as discussed previously). The cut-out 2830 r may provide asubstantially blunt edge in order to minimize abrasion or cutting of thesuture 240 against a sharp edge of the trap 2816.

Features in the Proximal Portion

Gap or Spacing for Suture Management

Counter-Bore Formed within the Device Proximal Portion

As the trap 2816 is withdrawn into shaft 16 of the proximal housing (asdiscussed previously), the suture 240 may double back or fold ontoitself. As discussed above, a gap or spacing 2830 p may be provided inthe form of a counter-bore 2832, between the exterior of the trap 2816and interior of the shaft 16 to accommodate the suture 240.Additionally, the counter-bore 2832 may also provide sufficientroom/space to allow the knot 250 to be positioned adjacent the styletand the trap 2816.

More specifically, the knot 250 may become positioned around the stylettip 2820 and may become lodged against the trap 2816, as the stylet 2819is withdrawn. As the stylet is withdrawn, tension is applied to thesuture 240 to pull it through the tissue, which is resisted by the knot250 as it in unable to go back (move proximally) through the trap 2816(For example, between fingers of the trap 2816). Thus, being in tensionbut being unable to pass back through the trap, the knot 250 may becomepositioned beside the stylet 2819. As a result, a spacing or gap (suchas counter-bore 2832) is provided within the shaft 16 to accommodate theknot 250 beside the stylet 2819, while the needle/trap/stylet areretracted out of the tissue receiving gap 2810. Thus, the counter-bore2832 provides sufficient space to substantially prevent damage to suture240 and may additionally prevent the device 100 from failing (e.g. dueto binding of the mechanism due to the suture 240 being pinched, forexample between the trap and/or stylet and the interior of the shaft16).

Thus, some embodiments of the present invention provide a means tosubstantially prevent the device 100 from failing. More specifically,some embodiments of the present invention provide a means to preventsuture 240 from getting pinched between various components, in order toprevent the device mechanism from binding (or in other words in order toprevent the moveable components of the device from getting jammed).

Features for Facilitating Routing of the Suture

Furthermore, in some embodiments the device 100 comprises features toallow suture 240 to be routed within the proximal portion or housing 14to prevent the suture 240 from getting entangled or damaged. In one suchembodiment, as discussed previously and shown in FIG. 22g , the suture240 comprises a first portion forming a post having a service loop, andlongitudinally opposed second portion forming a locker. In one example,the service loop of the post and the locker may be relatively long andmay stored within a handle of the device proximal portion 14, in orderto minimize the risk of suture 240 tangling. However, the locker andpost may be stored such that the suture 240 can be deployed withrelative ease during use. In a specific example of this embodiment,suture routing tubes are provided within the handle, and the first andsecond portions of the suture 240 are individually routed through one ofthe tubes and housed therein. In alternate embodiments, the suture 240may be routed through a spool payout mechanism. In still otherembodiments, the first and second portions of the suture 240 may beguided through clips or separate channels within the proximal portion 14to prevent the suture from getting entangled.

Example 2

Alternative suture management features will now be discussed withreference to an alternative embodiment of a suture passing device. Inthis alternative embodiment, the device incorporates a ‘suture passingassembly’ 2922 which may, for example, include any of the following:needle 116, stylet 2919, and/or a suture holder 2916, etc. In otherwords, in this alternative embodiment, there may or may not be a stylet,and suture holder 2916 may be passed both ways through the tissue (i.e.proximally through the tissue and then back distally).

In one specific example, the elongate member may comprise a combinationof the stylet 2919 and the needle 116. In another example, the elongatemember forming the suture moving assembly 2922 may comprise a needle116, without a stylet. In some embodiments, the suture moving assembly2922 may be operable to pass suture 240 between shaft 16 and the distaltip 12 (distally or proximally), to pass suture 240 through tissue. Inother embodiments, the suture moving assembly 2922 may be operable topass a suture holder 2916, with suture 240 coupled or secured thereto,between the shaft 16 and distal tip 12 (distally or proximally). In someembodiments, the suture moving assembly 2922 may be operable to firstdraw suture 240 between the distal tip 12 and the shaft 16 proximallythrough a first segment of tissue and then pass suture 240 (with orwithout a suture holder 2916) distally through a second segment oftissue.

As discussed above with respect to Example 1, the various features willbe identified with reference to the movement of suture 240 using theembodiment of device 100 shown in FIG. 29.

Features Used, for Example, During Initial Passing of Suture DistallyThrough Tissue

A Gap or Spacing for Suture Management

A Gap or Spacing Formed within the Proximal Shaft

In one example, as shown in FIG. 29a , a device 100 is disclosed forpassing a suture 240 through a region of tissue. Device 100 comprises adevice proximal portion 14 comprising a shaft 16 that is coupled to adevice distal tip portion having a distal tip 12. The device 100 furthercomprises a suture moving assembly 2922 housed within the device 100 formoving a suture 240 between the device proximal portion 14 and thedistal tip 12. A part of the suture moving assembly 2922 may be housedwithin the device proximal portion 14 (for example within a lumen orchamber 16B defined by shaft 16 of the proximal portion 14) and a partof the suture moving assembly 2922 may at least partially be receivablewithin the distal tip 12 (for example within a chamber 12B defined bythe distal tip 12). The suture 240 may be operably coupled to one ormore components of the suture moving assembly 2922. In some embodimentsof the present invention, the chamber 16B within the shaft 16 (of thedevice proximal portion 14) and chamber 12B within the distal tip 12,each include a spacing or gap (formed between components of suturemoving assembly 2922 and an inner wall of either shaft 16 or distal tip12, respectively) to allow the suture 240 to be passed substantiallywithout being damaged. In some embodiments, the width of chamber 16B mayvary along the length of the shaft 16. Thus, while chamber 16B in FIG.29a is shown as referring to the narrower, proximal portion of the shaftlumen, it also refers to the wider, more distal portion of the shaftlumen as shown, for example, in FIG. 29 d.

In one embodiment, the device 100 is positioned within tissue such thata first segment of tissue 201 is received within the tissue receivinggap 2910. As shown in FIG. 29b , when the suture moving assembly 2922 ishoused within shaft 16, a (minimal) gap or spacing forms between anouter surface of the suture moving assembly 2922 and an inner wall ofthe shaft 16. In the specific example shown, the gap or spacing isdenoted by reference numeral 2930 p. Gap 2930 p may, in someembodiments, comprise a counter-bore or offset recess.

Advantages of the Gap/Spacing in Preventing Damage to Suture

As shown in FIG. 29b , the gap or spacing 2930 p between suture movingassembly 2922 and shaft 16, provides sufficient room to prevent suture240 from getting pinched between the suture moving assembly 2922 (as itis advanced) and the shaft 16, for example by folding onto itself asshown in FIG. 29b , and thus may substantially prevent pinching of thesuture which can lead to chafing, fraying or other damage to the suture.

Advantages of the Gap/Spacing in Preventing Binding/Jamming of theDevice

Additionally, the gap or spacing 2930 p substantially prevents (orminimizes the risk of) jamming/locking of the device by preventingpinching of the suture. In other words, in some embodiments, the gap orspacing 2930 p allows for improved routing of suture 240 which maysubstantially reduce the risk of failure of device 100. Morespecifically, the gap or spacing 2930 p may help prevent the suturemoving assembly 2922 or any of the moving components within device 100from binding or jamming due to the suture 240. In other words, the gapor spacing 2930 p prevents the suture moving assembly 2922 from lockingdue to the suture 240 getting caught between the suture moving assembly2922 and the shaft 16, thus interfering with its advancement.

A Gap or Spacing Formed within the Distal Tip

Similar to the gap or spacing 2930 p present within chamber 16B of shaft16 of the proximal housing 14, chamber 12B defined by the distal tip 12may also define a spacing or gap, denoted by 2930 d in FIG. 29c . Thesuture moving assembly 2922 is advanced distally to pass suture 240through a segment of tissue, and advanced further towards the distal tip12, to couple the suture 240 thereto. In the embodiments as shown inFIG. 29c , the suture moving assembly 2922 is advanced until a portionof the assembly 2922 is received within the device distal tip 12. In onespecific example, a suture holder 2916 of the suture moving assembly2922 is positioned within chamber 12B of the distal housing. A gap 2930d is formed between the outer diameter of the suture holder 2916 andinner walls of distal tip 12 defining chamber 12B. The gap 2930 d allowsthe suture 240 to be routed so that it is not pinched or caught betweena portion of the distal tip 12 and the suture moving assembly 2922. Insome examples, the suture moving assembly is rotated to couple thesuture holder 2916 to the distal tip 12, and an additional relief or gapmay be provided which may allow the suture holder 2916 to be coupled tothe distal tip 12 substantially without damaging the suture 240. Afterthe suture holder 2916 has been deposited at the distal tip 12 (in thoseembodiments that function in this manner), the stylet 2919, or otherelongate member, is then withdrawn proximally and received within theproximal portion 14. The gap 2930 d may also help minimize damage to thesuture as the elongate member is withdrawn proximally. It should benoted that the drawings are not drawn to scale and, as such, gap 2930 dmay, in some embodiments, be sufficiently large so as to allowsufficient space for manipulation of the various components describedherein while limiting/preventing suture 240 from being constrained ordamaged. For example, in some embodiments, gap 2930 d is suitablydimensioned so as to prevent suture 240 from being manoeuvred intoposition between components of suture moving assembly 2922 and the innerwall of distal tip 12.

Features Used During Withdrawal of Suture Proximally Through Tissue

Surface Modifications for Suture Management

In some embodiments, device 100 may be repositioned as shown in FIG. 29d, so that a second segment of tissue 202 is received within the tissuereceiving gap 2910. In one example, device 100 is rotated pulling suture240 towards the axis of rotation of the device. In the example shown,the suture 240 is pulled towards the neck 15. In order to prevent thesuture 240 from getting caught and chafing a relief cut-out 2930 r maybe provided. The relief 2930 r may be formed within the distal tip 12adjacent the neck 15 (as shown). Alternatively, or in addition, acut-out may be present within a part of the suture moving assembly 2922,such as within the suture holder 2916. The relief cut-out 2930 rprevents or limits the suture 240 from being frayed or cut by a sharpcorner or edge of the distal tip 12 and/or a corner of the part of thesuture moving assembly 2922, such as suture holder 2916.

After the device 100 (with the suture holder 2916 coupled to the distaltip 12) has been rotated along its axis to receive the second segment202 of tissue within the tissue receiving gap 2910, components of thesuture moving assembly 2922 are re-advanced towards the distal tip 12 toretrieve the suture. As these components enter the distal tip 12 for thesecond time there may be risk of damage to the suture, such as fraying,or risk of the device being jammed/locked due to pinching of suture 240.The spacing or gap 2930 d within the distal tip 12, as well as anycut-outs present, for example in the distal tip and/or the sutureholder, may help minimize the risk of damage to the suture 240 and/orfailure of device 100.

The suture moving assembly 2922 is then withdrawn so that the suture 240is now drawn/passed from the device distal tip 12, through the secondsegment 202 of tissue, to the device proximal portion 14. The spacing orgap 2930 d (described earlier) as well as the relief cut-outs, such ascut-out 2930 r, may additionally help prevent damage to the suture andreduce the risk of the device 100 jamming as the suture moving assembly2922 is withdrawn proximally.

In other words, gap 2930 d, as well as any relief cut-outs or othersurface modifications, help mitigate the risk of suture damage and/ordevice failure both when the suture moving assembly enters the distaltip as well as when it is retracted along with the suture.

Gap or Spacing for Suture Management

As the suture moving assembly 2922 is pulled back into shaft 16 of theproximal housing, spacing is provided to accommodate the suture 240beside the suture moving assembly 2922. As described previously, a gapor spacing 2930 p is provided within the proximal shaft 16, whichprovides sufficient space to substantially minimize chafing or frayingof the suture 240. In one specific example, the spacing 2930 p is in theform of a counter-bore 2932, as shown in FIG. 29e . The counter-bore2032 provides sufficient room within the shaft 16 to prevent the suture240 from being pinched between a part of the suture moving assembly 2922(as it is retracted) and the shaft 16.

Alternative Embodiment of a Device for Passing Suture

In an alternative embodiment as shown in FIG. 20A, a device 100 isprovided that is similar to the embodiments discussed above. The distaltip 12 has receiving chamber 12B for receiving and holding a sutureholder such as a trap 2016 therein. The distal tip 12 comprises a slot2040 axially disposed along an outer surface thereof. Slot 2040 isformed from two substantially rectangular slots 2040 a and 2040 b, withslot 2040 b being positioned distal to slot 2040 a. The two slots 2040a, 2040 b are spaced apart by a pair of inwardly directed tabs 2040 cthat extend into the slot 2040. In one example, the tabs 2040 c comprisea resilient material.

Similarly, the trap 2016 also comprises a slot 2042 that is axiallydisposed along its outer surface, as shown in FIGS. 20B, 20C and 20D.Trap 2016 comprises a pair of inwardly directed tabs 2042 c that extendinto the slot 2042. The tabs 2042 c can be formed from a resilientmaterial and can deform when sufficient force is applied. Trap 2016 isheld within the chamber 12B of the distal tip 12 such that slots 2042and 2040 are aligned with each other. The slots 2042 and 2040 arepositioned such that tabs 2042 c, 2040 c are offset from each other.Tabs 2042 c of the trap 2016 are positioned distal to tabs 2040 c of thedistal tip 12 such that clearance is provided to pass/route a suture 240through the slot 2042 and into slot 2040 b. An alternative method of useof the device is described with respect to the embodiment shown in FIG.20A and is described herein below.

Method of Use

Hybrid Method

Device 100, in accordance with an embodiment of the present inventioncan be used to repair tissue defects. Thus, according to another aspectof the present invention there is provided a method of treating a defectin a tissue. The method is effected by passing a portion of a suturethrough a first region of the tissue positioned around the defect andcoupling a suture portion to a suture holder. The suture holder is thenretrieved through a second region of the tissue which is across thedefect from the first region thereby forming a knotable loop. The loopcan then be tied to close the defect.

Use of device 100 in repairing a tissue defect is described in greaterdetail below with reference to FIGS. 2a-3d . The tissue defect repairedby the present device can be, for example, a tear in annulus fibrosustissue or a defect formed in the annulus fibrosus as part of adiscectomy procedure. Tissues that may be treated using embodiments ofthe present invention include, but are not limited to: annulus fibrosustissue of an intervertebral disc, meniscal tissue of the knee, muscletissue, ligaments, tendons or other tissues of the shoulder or othersoft tissues within a patient's body, for example tissues that areamenable to arthroscopic treatment or are amenable to suturing. In onespecific example of a method of treating a defect within the meniscus,the defect may non-limitingly include delamination or tears of themeniscus (as mentioned previously) and a method of the present inventionmay be useful to reverse the delamination, or secure/contain the tear.

Other applications of a method of the present invention may includetreatment of a defect, such as a tear within a ligament, a defect withinpercutaneous tissue, or a defect within the outer surface of tissue suchas skin. Still further examples of a method of the present invention mayinclude use within surgical procedures or in vessel repair, shoulder orhip repair.

For example, when treating a defect in the annulus fibrosus tissue of anintervertebral disc, device 100 is inserted at the site of the defect300, as illustrated in FIG. 2a . In some embodiments, the device 100 issized and configured to be usable through a surgical portal that may beplaced at the treatment site as part of a discectomy or other surgicalprocedure. The device 100 is inserted through defect 300 such thattissue 200 is received within tissue receiving gap 10. Distal tip 12 isinserted through the defect and positioned within substantially withinthe nucleus pulpous while proximal portion 14 is positionedsubstantially outside the annulus fibrosus with neck portion 15 ofdevice 100 positioned through the defect. A suture passing member (e.g.stylet 319) is initially positioned within proximal portion 14 on aproximal side 200 a of tissue 200 and a suture holder 316 coupled todistal tip 12 is positioned on a distal side of the tissue 200 b. In oneexample, tissue on a first side of the defect 300, which may be referredto herein as a “first segment” 201 of tissue, is positioned within thetissue receiving gap 10, as illustrated in FIG. 2a . Activation oftrigger 218 (shown in FIGS. 1a-b ) translates stylet 319 from theproximal side 200 a to the distal side 200 b through the tissue attissue region or site P1. As is illustrated in FIG. 2b , a tissuepuncturing member such as needle 116 can be used to penetrate tissue 200at puncture site P1 prior to advancing stylet 319. Alternatively, needle116 and stylet 319 can be advanced together. Needle 116 may create adesired first puncture through puncture site P1. The puncture is createdthrough a first location within the first segment of tissue 201 at somedistance from the defect 300 on a first side of the defect 300.

When device 100 is positioned within tissue 200 as described above, itmay be angled such that the amount of tissue between defect 300 andpuncture site P1 (the ‘bite depth’) is maximized. This helps to maximizethe distance (from defect 300) at which the suture 240 is passed throughthe tissue, thereby reducing the likelihood of suture 240 tearingthrough the tissue when tension is applied to suture 240. Such anglingcan also be used to pass suture 240 through tissues that are thicker orare better capable of holding the suture (such as more fibrous tissuefor example) than tissues adjacent to defect 300. In some examples, thesuture 240 is passed through tissues that may be preferable, in thatthey are better able to retain or support the suture 240.

Once the knot 250 is retained by suture holder 316 as shown in FIG. 2d ,stylet 319 is retracted, leaving the knot 250 coupled to the sutureholder 316 at the distal tip 12 (see FIGS. 2e and 2f ). Device 100 canthen be repositioned such that region P2 of tissue 200 (across defect300) is positioned within tissue receiving gap 10.

As shown in FIG. 2c , needle 116 and stylet 319 can be advanced togetherfollowing puncturing through P1 to abut and stop against a proximal faceof suture holder 316, positioned at distal tip 12. In one specificexample, as mentioned above the suture holder 316 includes a trap 416with a bevel at its proximal end face and the needle 116 may also bebeveled at its distal end, to allow engagement with the beveled end faceof trap 416. In some examples, there may be a partial interactionbetween the beveled end face of trap 416 and the beveled distal end ofneedle 116. In other words, the trap and the needle may meet only alonga portion of their end faces. In one such embodiment, the partialinteraction between needle 116 and trap 416 allows a channel or gap 334to form there-between as shown in FIG. 3b . This allows for a portion ofsuture 240 to be passed through channel or gap 334 to help preventsuture 240 from being cut, frayed or severed. The interaction betweenthe needle 116 and trap 416, in some embodiments, may be sufficient toprevent the suture knot 250 from inadvertently escaping through thechannel 334. In another example, there may be a complete end to endinteraction between the beveled end face of the trap and the beveleddistal end of the needle 116. In other words trap 416 and needle 116 maymeet substantially along their entire end faces.

In one example, stylet 319 advancing the suture knot 250, is advanceddistally through suture holder 316 such that suture knot 250 is coupledto, or engages, the suture retaining element of suture holder 316. Thedistal end of stylet 319 pushes the suture knot 250 into suture holder316, allowing suture knot 250 to be positioned on the distal side oftissue 200. Suture holder 316 allows substantially one way travel of thesuture knot 250, i.e. suture holder 316 allows the suture knot 250 topass substantially distally through the suture holder 316 (for examplethrough an opening at the distal end of the suture holder 316) whileimpeding or preventing the knot 250 from being retracted through thesame opening once it is passed therethrough.

As illustrated and discussed in greater detail below, the stylet 319pushes the knot 250 through the suture holder 316 such that it exitsthrough an opening on the distal side of the suture holder 316. A distalportion of stylet 319 is received within the suture holder 316 withoutbeing permanently coupled or secured thereto; in other words, the styletis received in a manner whereby the stylet 319 is free to retractindependently from the suture holder 316. In a particular embodiment,the suture holder 316 comprises a resilient material which allowsmovement of the stylet 319 into suture holder 316 and allows the knot250 to be pushed through the suture holder 316 such that it is retainedon the distal side of the suture holder 316.

Once the knot 250 is retained by suture holder 316 as shown in FIG. 2d ,stylet 319 is retracted, leaving the knot 250 coupled to the sutureholder 316 at the distal tip 12 (see FIGS. 2e and 2f ). Device 100 canthen be repositioned such that region P2 of the second segment of tissue202 (across defect 300) is positioned within tissue receiving gap 10. Inone specific example, as shown in FIG. 3a , the device 100 is rotatedabout 180 degrees to position the device 100 at region P2 on theopposing side of the defect 300. In some such embodiments, the device isrotated approximately 180 degrees prior to passing the suture throughregion P2. Device 100 can also be repositioned such that the sutureholder 316 is retracted through a second location through the firstsegment 201 of tissue on the same side of defect (P3).

In order to retrieve suture holder 316, a suture holder retrievingelement such as stylet 319 is then re-advanced through, for example,tissue site P2, along with a tissue puncturing element such as needle116 or following puncturing of tissue 200 by needle 116. Once needle 116is passed through tissue 200, it abuts against a surface of sutureholder 316 which impedes further advancement of needle 116 as shown inFIG. 3b . Stylet 319 is then advanced further through suture holder 316and engages suture holder 316, as illustrated in FIG. 3c . Suture holder316 allows substantially one way travel of the stylet 319, relative tothe suture holder 316, thereby allowing the stylet 319 to traveldistally through suture holder 316, while substantially limiting orpreventing proximal movement of stylet 319 there-through (once thestylet has been advanced beyond the portion of the suture holderconfigured to engage with the stylet). Stylet 319 is then retractedthrough the tissue site P2 (which is displaced across defect 300 fromP1), for example on the second side 202 of the defect, but before stylet319 is retracted, the suture holder is disengaged from distal tip 12which allows it to be retracted along with stylet 319 as shown in FIG.3d . The ends of suture 240 may be tied to allow for a substantially360° suture loop to be placed around defect 300. In some examples,suture holder 316 is resilient and comprises a structure and/or materialthat provides both flexibility and elasticity, while having sufficientrigidity to allow the stylet 319 to remove the suture holder 316 fromthe distal tip 12 during retraction of the stylet 319. These propertiesof rigidity and flexibility may help prevent backward or proximalmovement of the stylet 319 relative to the suture holder 316 as notedabove.

Thus, when the stylet 319 is retracted through the tissue site P2, thesuture holder 316 is retracted along with the stylet 319. This allowsthe suture knot 250 to be withdrawn proximally through tissue site P2using the suture holder 316. In one embodiment, as shown in FIG. 3d ,the suture holder is drawn from the distal side of the tissue 200 (forexample, the internal surface of the tissue), to the proximal side ofthe tissue 200 (for example, the external surface of the tissue). Thus,the suture 240 has been passed through tissue sites P1 and P2 and acrossa region of tissue 200 or across tissue defect 300.

In some embodiments, the device may be rotated, for example by 90degrees, prior to withdrawing the device from the tissue. In oneparticular example, if the device 100 had previously been rotated in aclockwise direction prior to passing suture 240 through the secondsegment of tissue, the device 100 may be rotated again approximately 90degrees in a clockwise direction before withdrawing the device 100 fromthe tissue. Alternatively, if the device 100 had previously been rotatedin a counter-clockwise direction prior to passing suture 240 through thesecond segment of tissue, the device 100 may be rotated approximately 90degrees in a counter-clockwise direction before withdrawing the device100 from the tissue. In other words, the device 100 may be rotated byabout 90 degrees in the same direction as it was previously rotatedbefore withdrawing the device 100 from the tissue. This may help toensure that a portion of the device does not catch or snag a portion ofsuture 240 as the device is withdrawn from the patient's body. In otherembodiments, device 100 may be retracted without rotation, taking carenot to snag or grab the suture while retracting.

A closure knot 252 may then be provided to approximate tissue flankingthe defect 300. In some examples, the closure knot 252 is provided as apre-tied knot. In other examples, the closure knot 252 is formed bytying the ends of suture 240. The embodiments of a device and methoddescribed above may aid in approximation of a defect within the tissueand can be used for example to provide a suture loop that substantiallycompletely encircles the defect. More specifically, defect 300 may thenbe treated by approximating the defect 300 by securing the suturestrands that have been passed through both regions P1 and P2, on thefirst and opposing sides of the defect 300 using a closure knot. Theclosure knot may be formed during the procedure or may be in the form ofa pre-tied knot that is tightened to approximate the tissue by bringingtissue on the first and second sides of the tissue together.

An overview of the specific embodiment of a method of the presentinvention, as described above, is illustrated in FIGS. 8a and 8b . FIG.8a shows steps involved in depositing a suture knot at the distal tip,in accordance with a method of the present invention, the steps beingshown in order from top to bottom. Initially, the device in its startingposition is positioned at a desired tissue location. The needle thenpenetrates through the tissue (with the stylet and suture being housedwithin the needle). Thereafter, the stylet advances and pushes sutureknot through the trap. The stylet and needle then retract from tissueand suture end such as suture knot remains through the trap. FIG. 8bshows steps involved in retrieving the trap from the distal tip, thesteps being shown in order from top to bottom. The surgeon thenrepositions the device for second needle stick. The needle penetratestissue (the stylet being housed within needle). Then the stylet advancesuntil its tip is captured by the trap. The retention wire is thenretracted from the trap. The needle, trap, stylet and suture thenretract from tissue.

In accordance with various embodiments of methods described hereinabove, one or more of the steps may be automated.

Although one embodiment of a method is described herein above, whichinvolves passing a portion of a suture through a tissue site on one sideof the defect to couple the suture portion to a suture holder, andretrieving the suture holder through an opposing side of the defect,alternative embodiments for practicing the invention exist. Certainalternatives are described herein, but other alternatives are possibleas well.

In one alternate embodiment, the method of the present invention maycomprise initially passing the suture holder (with a portion of a suturedetachably coupled thereto) through a first tissue site on one side ofthe defect, and subsequently retrieving the suture portion through asecond tissue site an opposing side of the defect, i.e. reversing theorder described above.

In another alternate embodiment, the method of the present invention maycomprise retrieving a portion of a suture for example from a devicedistal tip placed on a distal side of the tissue, passing the suturethrough a first tissue site such that it is passed from a distal side ofthe tissue to the proximal side of the tissue, and capturing it within asuture holder (e.g. within the device proximal portion). The method mayfurther comprise passing the suture holder through a second tissue site,such that it is passed from the proximal side of the tissue to thedistal side of the tissue and coupling the suture holder to the devicedistal tip. In one example, this may allow for an internal knot to beplaced within the tissue.

In another alternate embodiment, the method of the present invention maycomprise passing a portion of the a suture through a soft tissue on oneside of the defect and coupling the suture portion to a suture holdercomprising a suture anchor, whereby the suture anchor is then retrievedthrough an opposing side of the defect.

Method of Dropping or Deploying a Suture Knot in Accordance with VariousEmbodiments of the Present Invention

Method of Deploying a Suture Knot Disposed on an Elongate Member Using aSuture Retaining Member

As described hereinabove, in some embodiments a device 100 may beprovided for deploying a partially or fully pre-tied knot with thedevice additionally comprising a suture retaining component 900 forretaining a portion of the suture as shown in FIGS. 21a-e . In someembodiments of the present invention as discussed earlier with respectto FIGS. 2 and 3, the device 100 may be used to deploy a closure knotafter the suture has been passed through for example, first and secondsegments of tissue on both sides of a defect, in order to re-approximatetissue on both sides of the defect 300. In other words, a device may beused to deploy a knot to substantially re-approximate the defect 300 bybringing together the first and second tissue segments around the defect300. The embodiments of a device and method described above may aid inapproximation of a defect within the tissue and can be used for exampleto provide a 360 degree suture loop, i.e. a suture loop thatsubstantially completely circumscribes the defect.

During use, the device 100 is withdrawn proximally along with segment703 a of the post 703 coupled thereto until the suture 240 is taut, thusplacing the suture 240 in tension. Since the system is in tension, asthe device 100 (and thus segment 703 a of the post 703) is pulled orretracted further, the loops 700 fall or release distally off the device100 and segment 703 a of the post 703 is pulled proximally through theloops 700. In other words, the loops 700 are deployed or released oversegment 703 a of the post 703. When the loops are positioned over thepost 703, they form a knot 720 (FIG. 21b ). As shown in FIG. 21b , theloops are deployed at a distance d from the tissue 200. The distance bywhich the device 100 is withdrawn proximally is substantially equivalentto the distance the loops 700 are displaced distally. More specifically,the suture 240 is routed such that segment 703 a of the post 703 extendsfrom the distal end of the device 100 to tissue 200, and the post passesthrough tissue 200 with segment 703 b extending proximally from tissue200 back towards loops 700 to which it is integrally coupled. As aresult, the proximally directed force applied to segment 703 a of thepost 703 results in a distally directed force being applied to segment703 b of the post 703 which translates to a distally directed forceapplied against the loops 700, thus pulling them off the device 100 andonto the post 703.

The device 100 is then retracted further while the second portion 702 ofthe suture 240 forming the locker 704 is held by the retaining ortensioning element 900. In other words, the retaining or tensioningelement 900 provides resistance to movement by, for example, providing africtional force F_(f) (not shown in the drawings) against the locker704, thus preventing the locker 704 from slipping. As shown in FIG. 21c, as the device 100 is pulled/retracted, the device 100 (and thussegment 703 a of the post 703) is withdrawn proximally with respect tothe tissue 200 while the loops 700 of the knot 720 substantiallycollapse or cinch around the post 703. In some embodiments, the knot 720is cinched substantially at distance d (not necessarily the same as thedistance ‘d’ in FIG. 21b above) from the tissue 200 in proximity to adistal end of the device 100. In some embodiments, the position of theknot 720 with respect to tissue 200 remains unchanged as the knot 720 isbeing collapsed or cinched. Thus, in some embodiments, as describedherein, allow the retaining or tensioning element 900 to retain ormaintain tension on the second portion 702 of the suture strand 240(such as a locker 704) while the knot 720 is being cinched or collapsed.

Thus, in some embodiments, the device includes a means (such as theretaining or tensioning element 900) for limiting/preventing motion ofone portion of the suture strand 240, such as a second portion 702 ofthe suture strand 240, relative to another portion of the suture strand,such as a part of the first portion 701 of the suture strand, during atleast a part of the knot deployment procedure. For example, the devicemay limit motion of the second portion 702 relative to a part of thefirst portion 701 that is affixed to the device 100, while the knot 720is collapsed. More specifically, the retaining or tensioning element 900may limit movement of the locker 704 relative to a part of the segment703 a of the post 703 that is coupled to the device 100. In other words,the retaining or tensioning element 900 prevents motion of the secondportion 702 of the suture strand 240 relative to the device 100. In someembodiments, the means for limiting/preventing motion (such as theretaining element 900) may apply a frictional force and/or maintaintension on a portion of the suture 240. Retaining second portion 702within retaining element 900 may also be understood to allow motion ofparts of suture portion 701 relative to the retained suture portion 702.Put differently, if suture portion 702 would not be retained but wouldrather be free to move, then it would move at the same rate as otherparts of the suture and there would therefore be no relative motionbetween those suture portions; limiting motion of portion 702, however,allows other parts of the suture to move relative to portion 702. Thus,retaining suture portion 702 within retaining element 900 may functionto either enable or prevent/limit relative motion between the sutureportions, depending on which portions of suture are examined.

As the knot 720 is cinched or collapsed, the device 100 is withdrawn orretracted further, relative to tissue 200. As shown in FIG. 21d , whenfurther collapsing the knot 720 requires a force that is greater thanthe force F_(f) applied by the tensioning or retaining element 900 tothe locker 704, the knot 720 begins to translate or slide distally alongthe post 703 (thus allowing the device 100 to be withdrawn) and thelocker 704 is released from the tensioning or retaining element 900.Some embodiments allow the locker 704 to be automatically released orwithdrawn from the retaining element 900, for example when the knot issliding, to avoid premature locking, excessive tightening or cinching ofthe knot 720. Releasing the locker 704, allows the locker 704 and theportion of post 703 affixed to device 100 to move relative to oneanother. In some embodiments, as shown in FIG. 21e , the device 100 iswithdrawn until the knot 720 slides to rest substantiallyadjacent/against tissue 200. This allows, for example, the suture 240 toplace tension on the first and second segments 201, 202 of the tissue200, in order to approximate the defect 300.

Thus in one broad aspect, embodiments of the present invention comprisea device having one or more features for: a) retaining/restraining aportion of the suture strand while tension is applied to another portionof the suture strand to cinch the knot; and b) releasing the portion ofsuture strand prior to the knot being locked or excessively tightened orcinched. In some embodiments, the suture as a whole is still retained bythe device at a different location along the suture length. In orderwords, the particular portion of suture that was retained by theretaining feature of the device may be released such that it is free tomove, while other portions of the suture strand may remain coupledto/retained by the device. It should be understood that the term“release” (and its cognates) may comprise an active or passive act ofreleasing (or a combination of the two), allowing/enabling, for example,relative motion between two portions of the suture strand. Thus,“releasing the one portion of suture strand” may thereby allow the oneportion of suture strand (for example, locker 704) to move relative toanother portion of the suture strand (for example a part of segment 703a of the post 703 that is coupled to the device 100).

Method of Deploying a Partially or Fully Pre-Tied Knot that isIndirectly Coupled the Device

As discussed above with respect to FIGS. 22a-f , a device may beprovided to deploy a pre-tied knot after the suture 240 has been passedthrough both first and second segments 201, 202 of tissue 200 (forexample around a defect 300), in order to bring the tissue segmentstogether. The device 100 of FIGS. 22a-f comprises a pre-tied knot interms of loops 700 that are indirectly coupled to the device shaft 16.The loops 700 are disposed onto a knot slider 800 that is mounted on thedevice shaft 16. After suture has been passed through the first andsecond segments of tissue 201, 202, a slight reduction can be observedin the amount of suture present in service loop L within the proximalportion or proximal housing 14, as shown in FIG. 22g . The device 100may then be withdrawn proximally and pulled away from the patient (theproximal direction is shown by arrow p). The suture within the serviceloop L is initially held by the force of friction F_(f) applied by theO-ring on the service loop L. The force F_(f) that is applied by theO-ring on the service loop L is less than the force required to decouplethe knot slider 800 from the shaft 16. In the embodiment where the knotslider 800 is passively coupled to the shaft 16 as shown in FIG. 22k ,the force F_(f) that is applied by the O-ring is less than the force offrictional engagement between the O-ring 910 and the shaft 16. As thedevice is pulled proximally the suture portion 701 is placed in tensionapplying a force F_(A) to the suture in the service loop L. Once theforce F_(A) exceeds the force F_(f) applied by the O-ring, the serviceloop L is pulled out of engagement with the O-ring. The service loop Lslips out from between the O-ring 910 and the projection 806, as shownin FIG. 22h . Thus, as the device 100 is drawn back the excess suture,i.e. the segment of suture portion 701 forming the service loop L isdeployed or pulled out from the proximal housing 14.

As the device 100 is withdrawn or retracted further, the excess suturefrom the service loop L is also consequently withdrawn. Once the excesssuture has been withdrawn, the slack in suture portion 701 has beenremoved and the suture portion 701 is placed in tension. As the device100 is further retracted, the taut suture portion 701 places tension onthe loops 700 wrapped around the knot slider 800. In other words, as thesuture portion 701 is placed in tension, force is applied to the loops700 formed around the knot slider 800, thus applying a force F_(B) (notshown in the drawings) on the knot slider 800. Force F_(B) is sufficientto disengage the knot slider 800 from the shaft 16 or any other part ofthe proximal portion 14 or device 100 to which it is detachably coupled.

Thus, when a sufficient force F_(B) is applied on the knot slider 800 astension is placed on the suture 240, the projection 820 of knot slider800 will move out of engagement from projection 1402 of the deviceproximal portion. The knot slider 800 is decoupled from the deviceproximal portion 14 and, as the device 100 is retracted/pulled, itslides distally along the shaft 16. The tail hook 824 of the knot sliderslides along the recess or groove 1603 of the shaft 16 until it reachesthe end of the groove 1603. The tail hook abuts against or engages aportion of the shaft 16. As shown in FIG. 23a , the knot slider 800 isthen positioned in its second configuration within the tissue receivinggap 10 of device 100. The knot slider 800 is positioned such that theflexible arm 818 is lined up with or adjacent the tissue receiving gap10.

Thus, when the device 100 is withdrawn proximally as discussed above,continued tension on the suture 240 causes the flexible arm 818 to bendor deflect (from its initial position 818A which blocks the loops 700)inwardly into the tissue receiving gap 10 into its second position 818Bto release the loops 700. The taper on the arm 818 may facilitatedeployment of loops 700. Additionally the downward taper on the knotslider 800 may also facilitate removal of the loops 700. When the armmoves into the gap 10, the tension applied by the suture 240 to the topportion of the loops 700, allows deployment of the loops 700 off theknot slider 800. The tension on the top portion of the loops 700 willpull the top portion forward and since the bottom portion of the loopsmay already be distally ahead of the top portion, and positioned on ataper, the loops 700 may slip/slide off the knot slider 800 well withrelative ease.

The remainder of the knot deployment method discussed herein below is inreference to the function of the retaining or tensioning element 900which in this particular example comprises the o-ring 910 discussedpreviously. With respect to FIGS. 21a-e and further illustrated in FIGS.23a and 23b , in some embodiments, suture portion 701 forms a post 703and suture portion 702 forms a locker 704 with post 703 comprisingsegments 703 a and 703 b. Once the knot slider 800 is in its second ordistal position, the device has been withdrawn such that suture portion701 (703) is in tension. The device 100 is then pulled further in aproximal direction, such that the loops 700 of the partially pre-tiedknot are released as shown in FIG. 23 b.

In further detail, in some embodiments the post 703 is routed such thatsegment 703 a of the post 703 runs distally from the device distal tip12 to the second segment 202 of tissue 200. The post 703 then passesthrough the second segment 202, along the opposite side/face of thetissue 200 and through the first segment 201 of the tissue 200. Postsegment 703 b then runs proximally from the first segment 201 of tissue200 to the loops 700. Thus, when the device 100 (and thus segment 703 aof the post 703) is retracted/pulled proximally while the locker 704 (ofsuture portion 702) is held by the O-ring 910, segment 703 b of the post703 exerts a “pulling” force on the loops 700 distally, allowing them tobe deployed or released onto the post 703 in proximity to the devicedistal tip 12. The positioning of the knot slider 800 within the tissuereceiving gap 10 prevents the loops 700 from being released within thetissue receiving gap 10. This prevents the loops from being deployedonto neck 15 of the device and collapsing or cinching thereon as theyare tightened. Since the knot slider 800 is positioned within the tissuereceiving gap 10, when the device is retracted/pulled, the loops 700 aredeployed distally off the knot slider 800 onto the first portion 701 ofthe suture 240 that is coupled to the device 100, i.e. the post segment703 a. Thus, the loops 700 are deployed distally onto the post segment703 a forming a knot 720 while tension is maintained on the locker bythe O-ring 910. In one example, the loops 700 are deployed at a distanced from the tissue 200, as shown in FIG. 23 b.

With further proximal movement of the device 100, the O-ring furtherfunctions to tension the suture 240 to aid in collapsing the loops 700of the knot 720. As device 100 is retracted, a segment 703 a of the post703 is withdrawn proximally while tension is maintained on the locker704 by the O-ring 910. The proximal movement of segment 703 a of thepost 703, while locker 704 is retained, applies a force F_(C) (not shownin the drawings) to suture 240 forming loops 700, causing the loops 700to collapse from a first diameter to a second smaller diameter, thuscollapsing the knot 720 around the post 703. The force F_(C) applied tothe suture to collapse the knot 720 is less than the F_(f) applied byO-ring 910 to the locker 704. Thus, the retaining or tensioning elementsuch as the O-ring 910 retains and/or restrains a second portion 702(forming the locker 704) of the suture 240 while tension is applied tothe first portion 701 (forming the post 703) of the suture 240 to cinchor partially cinch the knot 720.

More specifically, the O-ring 910 provides resistance against movementof the locker 704, preventing the locker 704 from moving which assistsin collapsing the knot 720. In other words, the O-ring 910 applies aretention force such as a force of friction F_(f) against the locker 704while the post 703 is tensioned. The knot 720 collapses until the forceto further collapse the knot is greater than the force/tension appliedby the O-ring on the locker 704. The knot 720 is collapsed distal to thedevice 100 in proximity to the device distal tip 12, as shown in FIG.23c . As the device 100 is pulled the knot 720 remains substantiallystationary with respect to tissue 200 with the device 100 movingproximally relative to tissue 200. An increase in length of suture isobserved proximal to the knot 720 between the knot 720 and the devicedistal tip 12 due to the decrease in length 1 of the loops 700 as theycollapse. The O-ring 910 places sufficient tension on the locker 704 toallow the knot 720 to collapse, but the tension is less than the forcerequired to lock the knot 720.

Once the knot 720 has been collapsed, additional force is required totighten or lock the knot 720. The device 100 is further retractedproximally, thereby retracting/pulling post segment 703 a and applying aforce F_(C) on the loops 700. When the force F_(C) is greater than theforce F_(f) applied by the O-ring 910 on the locker 704, the locker 704is released and the collapsed loops 700, and thus knot 720, slidedistally along the post 703 as shown in FIG. 23d . In other words, theapplied suture tension is greater than the frictional force applied bythe O-ring. This causes the locker 704 to move distally relative to theO-ring 910 causing the locker 704 to slide relative to the O-ring 910.Thus, the retaining or tensioning element such as the O-ring 910releases the second portion 702 (forming the locker 704) prior to theknot 720 being locked or excessively tightened or cinched. Morespecifically, some embodiments allow for retaining the locker 704 of thesuture 240 while the knot is being cinched while allowing the locker 704to be automatically released or withdrawn from the retaining ortensioning element, for example when the knot is sliding, to avoidpremature locking, excessive tightening or cinching of the knot 720. Inspecific example, when the knot 720 begins to slide, the locker 704 isno longer held in frictional contact with the O-ring 910 and may slipout completely from the O-ring. In other examples, the locker 704 may befree to slide or translate distally relative to the O-ring 910 but isheld by the O-ring 910 during the procedure. When the O-ring releasesthe locker 704 it allows relative movement between the locker 704 andthe part of segment 703 a of the post 703 that is coupled to the device100. The loops 700 continue to travel distally along the post 703 untilthey are in proximity to the tissue 200, as shown in FIG. 23 e.

Additional force may be applied to the locker 704 and/or the post 703 inorder to further tighten and/or lock the knot 720 for example in orderto approximate the defect 300. Furthermore, the locker 704 and the post703 may be used to create additional knots in order to further securethe knot 720. In one specific example, the additional knots arehalf-hitches. In a particular embodiment, four half-hitches are created.In another example, the additional knot is an overhand knot or surgeon'sknot. In one specific example, the additional knot is a double-overhandknot where either the post or the locker may be pulled to lock the knot.Alternatively both the post and the locker may be pulled simultaneouslyin order to lock the knot. In one specific example, the knot 720 issliding locking knot. In one specific example the knot 720 is a Dinesknot.

Alternative Embodiment of a Method of Deploying a Pre-Tied Knot Using aDevice Comprising a Retaining or Tensioning Element in the Form of aSpring Member

An alternative embodiment of a method of deploying a pre-tied knot asshown in FIG. 24. In operation, the device 100 is withdrawn to deploythe loops 700 distally off the device 100 at a distance from tissue 200.The loops 700 are displaced distally substantially by the same distancethat the device 100 (and thus segment 703 a of the post) has traveledproximally. After the loops 700 have been deployed forming a knot suchas a Dines knot 720, the device 100 is pulled proximally, withdrawingthe post segment 703 a coupled thereto while the locker 704 is retainedby the resilient member 912. In some embodiments, as force is applied tothe post 703, the Dines knot 720 collapses distal to the device 100 inproximity to the device at substantially the same distance from thetissue 200 at which the loops 700 have been deployed. The Dines knot 720collapses until the force applied to the post 703 to further collapsethe knot is greater than the retention force applied by resilient member912 on the locker 704. At this point the knot 720 begins to slidetowards the tissue and the loop Y of the locker 704 slips out ofengagement with the resilient member 912. Thus, although the resilientmember 912 retains the locker 704 while tension is being applied to thepost 703 to collapse or cinch the knot 720, it releases the locker 704as the knot 720 begins to slide, prior to the knot being locked orexcessively tightened or cinched. The device 100 continues to be pulleduntil the knot 720 slides to a position substantially adjacent thetissue. The knot 720 may then be locked by applying a force to thelocker 704 and/or the post 703.

In an alternate embodiment as described above with respect to thedescription of the device, the retaining or tensioning element 900 forholding the second portion 702 of the suture such as the locker 704, mayincludes two interlocking mechanical pieces. The first mechanical pieceinteracts with the second mechanical piece (i.e. the two pieces areco-operatively engaged with each other). The suture 240 is passedthrough tissue as discussed previously for embodiments described hereinabove. The device 100 is then withdrawn proximally to deploy loops 700onto the post 703 forming a knot 720. The device 100 is further pulledproximally to collapse the knot 720 until such time that the forcerequired to further collapse the knot 720 is greater than the holdingforce of the two mechanical pieces. Thus, similar to embodimentsdescribed above, the retaining or tensioning element 900 retains thesecond portion 702 of the suture 240 while tension is applied to thefirst portion 701 of the suture to cinch the knot 720 but allows thesecond portion 702 to be released or withdrawn, for exampleautomatically, when the knot is sliding to avoid premature locking orexcessive tightening or cinching of the knot 720. An example of thiscomprises a first resilient member coupled to the locker 704, the firstresilient member being coupled to a second resilient member that isattached to the device body similar to the example shown in FIG. 24.

Alternative Methods for Deploying the Loops of a Pre-Tied Knot areDescribed Further Herein Below with Respect to FIGS. 25-27.

In some embodiments as shown in FIG. 25a , the loops 700 of a partiallyor fully pre-tied knot are formed onto a portion of the shaft 16. Theloops 700 are formed distal to a retaining or tensioning element 900mounted on the device shaft 16. In one example, the retaining ortensioning element comprises an O-ring 910. As discussed previouslyherein above, the first portion 701 of the suture 240 extending from theloops 700 forms the post 703 with the post comprising segments 703 a and703 b. Whereas the second portion 702, extending from the loops 700,forms the locker 704. Similar to embodiments discussed previously, thedevice 100 is used to pass suture through the tissue 200. The suture 240is passed through both first and second segments of tissue, 201, 202 andthe device is then withdrawn proximally enabling the loops 700 of thepartially pre-tied knot to be deployed or released over the post 703 asshown in FIG. 25b , forming a knot 720 at a distance from the tissue200. Since the post 703 is connected to the device, extends distally,through the tissue and back proximally to the loops 700, as post segment703 a is retracted/pulled proximally, post segment 703 b is pulleddistally and pulls loops 700 distally off the device to form the knot720. The length of a portion of the suture 240 forming the loops 700 isdenoted as 1.

As the device is withdrawn further, post segment 703 a is pulled,tensioning the post 703, while the retaining or tensioning element 900in the form of the O-ring 910 restrains locker 704. The O-ringfrictionally engages the locker 704 allowing the tension in the post 703to collapse the loops 700 and thus knot 720. More specifically, as postsegment 703 a is pulled proximally relative to the tissue 200, anincrease in length is observed in each of post segment 703 a and thelocker 704. The increase in length is seen proximal to the knot 720between the knot 720 and the device distal tip 12 and is substantially aresult of the decrease in diameter or length 1 of the loops 700. Asshown in FIG. 25c , the extra suture 240 now seen in the post segment703 a and locker 704, proximal to the collapsed knot 720, is altogethersubstantially equal to the length of 1 of the suture originally formingloops 700 and is denoted by ½ for each of 703 a and 704. Thus, insummation, as the device 100 is pulled proximally, it collapses theloops 700, thus partially cinching the knot 720 (also shown in FIGS.25d, 25e ). The knot 720 is collapsed distal, and substantiallyadjacent, to the distal tip of the device 100. The loops 700 continue tocollapse until the O-ring 910 no longer resists movement of the locker704

The mechanism involved in collapsing the knot is further described inFIGS. 26a and 26b . As the device 100 is retracted, the post segment 703a is retracted along with it. The force with which the post segment 703a is retracted is denoted as F_(v) (not shown). The force that isapplied by the O-ring to retain the locker 704 is denoted as F_(f). Asthe post segment 703 a is retracted/pulled proximally, it results in aforce F_(v) being applied on the knot 720 which is less than the forceof friction F_(f) applied by the retaining or tensioning element 900 onthe locker 704. This allows the post 703 to collapse the knot 720, asshown in FIG. 26a and FIG. 26b . As the knot is collapsed, greater andgreater forces are required to tighten the knot, and eventually F_(v)applied by the post 703 is greater than F_(f) applied by the retainingor tensioning element 900. The locker 704 is then released from theretaining or tensioning element 900 and knot 720 slides distally alongthe post 703. The device 100 is retracted/pulled/withdrawn until theknot 720 slides to a position substantially adjacent the tissue. Thus,similar to embodiments described above, the retaining or tensioningelement 900 retains the locker 704 while tension is applied to the post703 to cinch the knot 720 but allows the locker 704 to be released orwithdrawn, for example automatically, when the knot is sliding to avoidpremature locking or excessive tightening or cinching of the knot 720.As the knot is 720 is slid to a position adjacent the tissue 200, thetension in the suture 240 allows the first and second segments 701,702of tissue to be approximated for example, to close a defect within thetissue. The knot 720 may be tightened by pulling the locker 704 and/orthe post 703. Additional knots may be formed on top of the knot 720 inorder to further secure the knot 720.

Similar to embodiments described above, another embodiment is shown inFIG. 27a , where loops 700 of the partial knot are positioned over orstored around a portion of the device 100, such as a component of theshaft 16 or a component mounted on the shaft 16, such as a slider 800′.The first and second portions of the suture 240 extending from the loops700 are routed under a retaining or tensioning element or tensioner 900positioned on the device shaft 16, proximal to the loops 700 and may bestored within the device proximal portion 14 such as within the handleof the device 100. The first and second ends of the suture 240 form thepost 703 and locker 704 respectively with the post 703 comprisingsegments 703 a and 703 b. The device 100 may be used to pass suturethrough first and second segments 201, 202 of tissue 200 around a defect300, similar to embodiments discussed previously. The device 100 is thenretracted/pulled/withdrawn such that the loops 700 of the partial knotare positioned over/about the post, completing or forming the knot 720as shown in FIG. 27b . In a particular example, the component onto whichloops 700 are mounted, such as slider 800′, slides until it ispositioned at a distal end of the device, with the loops 700 now beingpositioned over the post 703, forming the knot 720. The device 100 ispulled further so that the loops are deployed off the distal end of thedevice 100 onto the post 703 distal to the device 100. As describedpreviously, when the device is withdrawn further, the post segment 703 ais pulled, resulting in post 703 applying a force on the knot 720 whilethe retaining or tensioning element 900 maintains tension or pulls onthe locker 704 to cinch knot. This allows cinching or collapsing of theknot 720, as shown in FIG. 27c . As the device is further retracted, theforce applied by the post 703 is eventually greater than the force F_(f)applied by the tensioning or retaining element 900 on the locker 704.The locker 704 is released and the knot 720 begins to slide down towardsthe tissue 200. Thus, similar to embodiments described above, theretaining or tensioning element 900 retains the locker 704 while theknot 720 is being cinched while allowing the locker 704 to be releasedor withdrawn from the retaining element when the knot is sliding toavoid premature locking or excessive tightening or cinching of the knot720. The locker may be pulled fully through the tensioning or retainingelement. As the knot 720 slides towards the tissue 200, suture 240places tension on the first and second segments 201, 202 of tissue 200,in order to approximate the defect 300 as shown in FIG. 27d . In oneparticular example, a suture knot 250 that may be coupled to the suture(to assist in passing the suture) may remain in the device shaft 16while the post 703 is separated from the instrument.

Method of Use of Various Depth Selection and Interlock Mechanisms

Method of Use of Device 100 with Respect to the Manual Needle ReleaseButton and Manual Depth Selector as Described Herein Above

Manual Needle Release Button

As described above, the stylet is advanced beyond the needle by variousamounts during the course of a procedure. Various interlock and depthselection features (which allow the stylet 319 to decouple from theneedle 116, to advance to various distances) can be embodied in variousways as described previously. The specific embodiment of the manualneedle release button is described further in terms of the operation ofthe device. The details of the mechanism of device 100 is describedfurther with reference to FIG. 1a . The trigger 218 has a geared portion220 that co-operatively engages with a gear rack 434 of the stylet hub430 that is able to slide within the chamber 140 defined by the handleof device 100. The trigger 218 is coupled to a biasing mechanism such asa spring biased mechanism. When the trigger 218 is in a neutralposition, the spring is held against the bias. As the trigger isactuated (also shown in FIG. 4a ), the geared portion 220 of the trigger218 advances the gear rack 434 which further exerts a force against thespring bias. The stylet hub 430 translates distally with the gear rack434 causing the needle hub 130 (that is coupled to the stylet hub 430 bybutton 600 in its initial position 600A), to translate distally withrespect to the handle chamber. Additionally, needle 116 is advanced withthe needle hub 130.

The needle functions as a tissue puncturing member and in one example,advancement of needle 116 allows needle 116 to puncture tissue 200 atsite P1. As mentioned previously, in the illustrated embodiment of FIG.2b , the stylet 319 is housed within the needle 116 and is also passedthrough the tissue 200 at site P1. The stylet 319 functions as a suturepassing member and the suture 240 having a knot 250 is passed throughthe tissue using the stylet 319. The suture knot 250 is positionedadjacent the stylet tip and is carried distally by the stylet tip as itis advanced. As the needle 116 is advanced further it abuts against aproximal face of the suture holder 316 at the distal tip 12 and thetrigger 218 cannot be actuated further as shown by FIG. 2c . The needlerelease button 600 is then depressed (to position 600B, as shown in FIG.4b ), allowing the needle hub 130 to disengage from the stylet hub 430.This allows the trigger 218 to be depressed further and the stylet hub430 to translate distally with respect to the needle hub 130. Thisallows the stylet hub 430 to be advanced distally such that the stylet319 is received within the suture holder 316 to deposit the suture knot250 therein.

With reference to FIG. 2d , stylet 319 is advanced distally, to apredetermined distance required to deposit the suture knot 250, suchthat the knot 250 is coupled to the suture holder 316. The suture holder316 comprises a suture retaining component for retaining the suture knot250. FIGS. 4a-4g illustrate the operation of device 100 with respect toselective advancement of the stylet 319 with respect to the needle 116to allow a suture 240 to be passed through a first segment of tissue201. In accordance with a method of the present invention (discussedabove) the device 100 is then repositioned to then allow suture 240 tobe passed through a second segment of tissue 202 as shown in FIGS. 3a-3d. The trigger 218 may be re-actuated to re-advance until needle 116abuts the suture holder 316 (FIG. 3b ). Similar to the mechanismdescribed above, the needle release button 600 may be depressed again toposition 600B to remove the obstruction from interference block 601 toallow the stylet hub 430 to advance. The stylet 319 is then advanceddistally, further than the predetermined distance required to depositthe suture knot 250, such that the stylet 319 is coupled to the sutureholder 316 to retract the suture holder 316 with the stylet 319 (FIGS.3c-3d ). Thus, as can be seen in FIGS. 2d and 3c , in this specificembodiment of the present invention, the stylet 319, upon a firstactuation of the trigger, is initially advanced a certain distance todeposit the suture portion such as knot 250 through the suture holder316 (FIG. 2d ). Further, upon a second actuation of the trigger (afterrepositioning the device on the other side of the defect), the stylet319 is subsequently advanced a greater distance to capture the sutureholder 316 (FIG. 3c ). In order to allow for varying the distance towhich a stylet 319 is advanced when the trigger 218 is actuated, certainembodiments of the present invention provide a depth selection mechanism(depth selector) 500, as shown in FIGS. 5a, 5b and 6a -e.

Manual Depth Selector

The mechanism of the device 100 is now described with reference to thedepth selector 500. FIGS. 5a-5e illustrate operation of device 100 usingthe depth selector 500 (also referred to as the depth selection oradjustment mechanism) to advance the stylet 319 through a first regionof tissue to deposit the knot 250 within the suture holder 316 such thatthe stylet 319 functions as a suture passing member. Additionally FIGS.6a-6h illustrate operation of device 100 using the depth selector 500 toadvance the stylet 319 further to retrieve the suture holder 316 througha second region of tissue 200, such that the stylet functions as asuture holder retrieving member. As mentioned with respect to anembodiment of a device of the present invention, FIGS. 5a and 5billustrate the depth selector 500 is in its first/initial or startingposition or depth setting 500A and illustrate the starting and final(after trigger actuation) locations of the depth selection or adjustmentmechanism 500 with respect to the handle housing. In accordance with themethod, prior to actuation of the trigger 218, the device may beposition at a defect 300 as shown in FIGS. 2a-2d , to receive a firstsegment of tissue 201 the tissue receiving gap 10 so that suture 240 maybe passed through tissue adjacent the puncture site P1. With referencenow to FIG. 5d , the depth selector 500 is initially its first positionor initial depth setting 500A and is positioned such that the tab T ispositioned adjacent the stylet hub proximal portion 432. Thus, the tab Tis positioned distal to the stylet hub proximal portion 432. As thetrigger is actuated to advance needle 116 and stylet 319, the needlerelease button 600 is depressed as discussed above, The button 600 movesfrom its initial position 600A to 600B (Not shown) to allow the stylet319 to travel further than needle 116. At initial depth setting 500A,the tab T is positioned or contained between the distal surface of thestylet hub proximal portion 432 and the needle hub 130, and prevents thestylet hub proximal portion 432 from being further advanced to bepositioned flush with the needle hub 130. Thus, travel of the stylet hub430 distally within the handle chamber 140 is limited due to theinterference created by the tab T, resulting in the stylet hub proximalportion 432, being positioned at a distance Y2 (FIG. 5b ) from thedistal end of the handle chamber 140. This allows the stylet 319 toextend into the suture holder 316 (for example, trap 416) so that onlythe distal portion of the stylet and thus the suture knot 250 is passedthrough the suture holder 316, as shown in FIG. 2d . Thus, allowing thestylet 319 to function as a suture passing member. The stylet 319 doesnot couple to suture holder 316 and is free to travel back when thetrigger 218 is released.

FIG. 5e illustrates the step described above with respect to FIGS. 2eand 2f , whereby the trigger 218 is released, allowing the stylet 319 toretract while leaving the suture knot 250 engaged with the trap 416 atthe distal tip 12. After depositing the suture knot 250 through tissuesite P1, when the trigger 218 is retracted it allows the stylet hub 430to translate proximally, and further retraction of the trigger 218allows the needle release button 600 to move back to its first ororiginal position 600A to re-engage the needle hub 130 to the stylet hub430, as shown in FIG. 5e . In further detail, as the trigger isreleased, the stylet hub 430 translates proximally and spring 605returns to its uncompressed state allowing the needle hub 130 to bespaced at its nominal distance with respect to the stylet hub proximalportion 432. In other words, in FIG. 5e , the needle hub 130 and thestylet hub 430 both return to substantially the same position theyoccupied in FIG. 5c prior to trigger actuation). Previously, the button600 had been kept in the depressed position 600B by the stylet hub 430pressing against it. As the stylet hub is retracted, it no longerpresses on the button 600. The stylet 319 may then re-engage the needle116 with button 600 moving to its first position 600A (as the spring 603in the spring loaded button 600 recoils back to its uncompressed state),and both the stylet and needle 116 may then be automatically retractedtogether to their initial positions within proximal portion 14.

In accordance with FIG. 3a , the device 100 may be rotated and theposition of the device 100 adjusted to allow suture 240 to be drawnthrough a second segment of tissue on the other side of the defect 300.For example, in order to substantially seal the defect 300, the suture240 may be passed through tissue adjacent the puncture site P2. Thedepth selector may now be set to its second position or depth setting500B as shown in FIG. 6a (also depicted in FIGS. 4c and 4e ).

With reference to FIG. 6b , the trigger is actuated to allow the stylet319 and the needle 116 to be re-advanced from their initial positionssuch that the needle 116 punctures tissue at puncture site P2 on theother side of the defect. As outlined previously, the needle 116 isadvanced until it abuts against the suture holder 316 at the distal tip12. The needle release button 600 is then depressed, as shown in FIG. 6c, so that it moves from its first position 600A to its second position600B. This decouples the stylet 319 from the needle 116, allowing thestylet to advance into the suture holder 316 at the device distal tip 12to engage the suture holder 316, as shown in FIG. 6d and as describedpreviously with reference to FIG. 3c . Thus, allowing the stylet 319 tofunction as a suture holder retrieving member. Actuation of the depthselector 500 to its second depth setting 500B, as shown in FIG. 6a ,allows the stylet 319 to advance to a second distal position (e.g. asecond predetermined distal position) which is further distally,relative to the position described above with reference to FIGS. 2d and5b and which allows stylet 319 to engage or couple to suture holder 316.

As shown in FIG. 6e , the depth selector 500 may be moved into itssecond position by applying a transversally directed force F against thedepth selector 500, thereby moving the projection 501 of the depthselector into the second indentation 503 within the stylet hub, whichallows the depth selector to remain in its second position 500B (until acounter force is applied to move it back to its first position). Withreference now to FIG. 6e , when the depth setting 500B of depth selector500 is in its second position the tab T of the depth selector 500 is nolonger located between the distal surface of the stylet hub proximalportion 432 and needle hub 130. In this position, the depth selector tabT does not interfere with the advancement of the stylet hub 430 relativeto the needle hub 130. In other words, the tab T is located external tothe travel path of stylet hub 430. As the stylet hub 430 is advancedwithin the handle chamber 140 relative to the needle hub 130, thedistance the stylet hub 430 travels distally is not limited by the depthselector 500. In an alternative embodiment, during the second triggeractuation as the stylet 319 is advanced a second time, the distance thestylet hub 430 travels may also be limited by the depth selector 500.This allows the stylet hub proximal portion 432 to be positioned flushagainst the proximal surface of the needle hub 130, i.e. the stylet hubproximal portion 432 travels maximally with respect to the needle hub130 within the handle chamber 140, as shown in FIG. 6f . Thus, asillustrated in FIG. 6g , using the second depth setting 500B results inthe stylet hub proximal portion 432 being positioned at a closerdistance Y1 from the distal end of the handle chamber 140, compared todistance Y2 using the first depth setting 500A. This enables furtheradvancement of the stylet which allows the stylet 319 to extend into thesuture holder 316 (such as trap 416) so that it engages the sutureholder 316 as shown in FIG. 3 c.

With reference now to FIG. 6h , when the trigger 218 is released, thebiasing mechanism coupled to trigger 218, such as the spring-biasedmechanism, automatically urges the gear rack 434 of the stylet hub 430to translate proximally within the handle chamber 140. The stylet 319 isthen retracted when the trigger 218 is released, allowing the sutureholder 316 to be retracted along with the stylet 319 (as previouslydiscussed with respect to FIG. 3d ).

As noted above with respect to FIG. 3d , the distal tip 12 of device 100defines a receiving chamber 12B. The receiving chamber 12B receives thesuture holder 316 therein. The suture holder 316 comprises an engagementfeature for releasably coupling the suture holder 316 to the distal tip12. In one specific example of this, the suture holder 316 is initiallysecured within the receiving chamber using a wire 20 that engages thesuture holder 316. The wire 20 may be attached to a wire stop 18, shownin FIG. 6h . The wire 20 may be removed by pulling the wire stop 18, toallow disengagement of the suture holder 316 with the receiving chamber12B. This allows retraction of the suture holder 316, upon release ofthe trigger 218 (FIG. 6h ).

Method of Use of an Automatic Needle Release Button with an AutomaticDepth Selector Having a Mechanism for Generating an Audible Feedback asDescribed Herein Above.

Automatic Depth Selector with a Mechanism for Generating an AudibleFeedback

An alternative embodiment of the depth selector 500′ is described withreferences to FIGS. 6m-6x that comprises an additional mechanism forgenerating audible feedback indicating when the translation of thestylet 319 to each of its respective first and second translationdistances is complete. During the first actuation of the trigger, thestylet hub proximal portion 432 translates distally, allowing the depthselector 500′ coupled thereto to translate distally. As shown in FIG. 6n, the lower arm 507 of the depth selector 500′ is deflectable and flexesas tab 510 rides up along an upper surface 1403 a of the control rib1403 (which includes a tapered section 1403 t). Thus, the lower arm 507moves from its un-deflected position into its deflected position.Contrary to this, the upper arm 508 may not flex and remains in itsinitial position. In one example, the upper arm 508 is in contact withthe stylet hub proximal portion 432 which limits the upward movement ofarm 508.

As the stylet hub proximal portion 432 and the depth selector 500′ areadvanced further, the tab 510 on the lower arm 507 reaches the end ofthe control rib 1403 just prior to the stop 509 contacting the needlehub 130, as shown in FIG. 6o . As the tab 510 on the lower arm 507advances past the end of the control rib 1403, the arm 507 springs backto its un-deflected initial position as shown in FIG. 6p . As itdeflects back to its initial position it collides with click rib 1404,thus making a “click” sound. The “click” sound indicates that thetranslation of the suture passing element, such as the stylet 319 to itsdesired translation distance is complete. For example, the “click” mayindicate that the stylet 319 has been advanced to a distance to allowthe stylet to deposit a suture through a suture holder. As shown in FIG.6q (in which the components are in positions similar to those shown inFIG. 6p ), the stop 509 on the upper arm 508 touches the needle hub 130and thus limits further forward or distal translation of the stylet hubproximal portion 432. As the trigger is released as shown in FIG. 6r ,the stylet hub 430 retracts proximally towards its initial/startingposition. As the depth selector 500′ is retracted with the stylet hub430, tab 510 of the lower arm 507 slides along and past the proximal endof the click rib 1404, and is then guided along an upper surface 1405 aof control rib 1405. The tab 510 of the lower arm 507 then engages withthe control rib 1403 pivoting the depth selector 500′ downwards. A lowersurface 1403 b of the control rib 1403 along the tapered section 1403 tmay additionally guide/force the tab 510 of the lower arm 507 down, thusguiding/forcing the depth selector 500′ to deflect or pivot into itssecond position. Once the stylet hub 430 has been fully retracted uponrelease of the trigger, as shown in FIG. 6s , the depth selector 500′ isnow in its second position and is ready for the second actuation of thetrigger. The depth selector 500′ has been rotated downwards such that itwill not contact the needle hub 130, and will not impede/limit themovement of the stylet hub 430.

As the trigger is actuated again to advance the stylet hub 430, thedepth selector 500′ remains in its second position as shown in FIG. 6twith tab 510 of lower arm 507 translated distally until it abuts againstor engages the lower surface 1405 b of the guide or control rib 1405. Astab 510 of the lower arm 507 rides down/along the a tapered portion ofthe lower surface 1405 b of the control rib 1405, the lower arm 507flexes, whereas the upper arm 508 cannot flex and remains in itsposition as shown in FIG. 6u . The position of the upper arm 508 ismaintained by contact with the stylet hub 430. As the lower arm 507flexes the upper and lower arms 508, 507 are pushed apart from eachother. As tab 510 of the lower arm 507 reaches the end of the controlrib 1405, the lower arm 507 springs back to its un-deflected positionand collides with the click rib 1406 making a “click” sound, as shown inFIG. 6v . The “click” sound indicates that the translation of the sutureholder retrieving member, such as the stylet 319, to its desiredtranslation distance, is complete. In such an embodiment, the arm 507and rib 1406 may be understood to be components of a feature forproviding an indication that the suture passing member has been advancedby a desired amount. For example, the “click” indicates that the stylet319 has been advanced to a distance to allow it to engage with thesuture holder, which will allow the stylet 318 to withdraw the sutureholder along with it when it is retracted. As shown in FIG. 6v , duringthe second actuation of the trigger, the depth selector 500′ does notcontact needle hub 130, allowing further translation of the stylet hub430, which in turn allows the stylet to be advanced further for engagingwith the suture holder. The translation of the stylet hub 430 is limitedby a wire puller 1801 also shown in FIG. 6v . The trigger is thenreleased allowing the stylet hub 430 to retract, allowing depth selector500′ to retract therewith. As illustrated in FIGS. 6w and 6x , the depthselector 500′ is guided by control ribs 1405 and 1403 as it isretracted, allowing it to pivot back to its second position.

Method of Use of an Automatic Needle Release Button Along with the DepthSelector Described Presently Above.

During the first actuation of the trigger, as the stylet hub 430translates distally, it allows the needle hub 130 to translate distallyto the position shown in FIG. 6n . The ramp 402′ of the stylet hub 430engages ramp 602′ of the button 600′ that is coupled to the needle hub130 as shown in FIG. 6n (i), pushing the needle hub 130 distally. Thehook 604′ of the button 600′ is now positioned past the tab 1408 asshown in FIG. 6n (ii).

As the trigger is actuated further, the needle coupled to the needle hub130 may encounter tissue resistance. In some embodiments, resistance maybe observed as the needle abuts against the suture holder at the distalend of the device. This causes the ramp 402′ on the stylet hub 430 todepress the ramp 602′ on the needle hub 130 as shown in FIG. 6o (i). Astab 1408 is no longer preventing the hook 604′ of the needle releasebutton 600′ from retracting, the needle release button 600′ moves to itsdepressed or second position 600B′, illustrated in FIGS. 6o (i) and 6o(ii). The stylet hub 430 and the needle hub 130 disengage from eachother and are no longer operationally coupled. This allows the stylethub 430 to advance relative to the needle hub 130 as shown in FIGS. 6o,6p and 6q while keeping the needle release button 600′ in its depressedposition 600B′. This is further illustrated in FIGS. 6q (i) and 6 q(ii)by the translation of ramp 402′ of the stylet hub 430 past the needlerelease button 600 and the needle hub 130. In some embodiments, this mayallow the stylet to be translated to deposit a suture within the sutureholder at the distal tip of the device. The trigger is then releasedallowing the stylet hub 430 to retract or translate proximally. As shownin FIGS. 6r, 6r (i) and 6 r(ii), as the stylet hub 430 is retracted itno longer depresses the needle release button 600′ allowing it to returnto its nominal position 600A. The needle hub 130 and the stylet hub 430are coupled once again. As shown in FIGS. 6s, 6s (i) and 6 s(ii), thestylet hub 430 and the needle hub 130 then translate further proximally.During this proximal translation, hook 604′ of the needle release button600′ rides below tab 1408 of the housing 14′ as shown in FIG. 6s (ii)and the button 600′ remains in its nominal position 600A.

Upon second actuation of the trigger, the stylet hub 430 is thenre-advanced The interaction between ramp 402′ of the stylet hub 430 andramp 602′ of the needle release button 600′ (that is coupled to theneedle hub 130), allows or forces the stylet hub 430 and the needle hub130 to advance together. Hook 604′ of the needle release button 600′rides below the tab 1408 until it is advanced beyond the tab 1408. Asshown in FIGS. 6t, 6t (i) and 6 t(ii), once the hook 604′ is positionedpast the tab 1408, further actuation of the trigger causes the stylethub 430 to depress the needle release button 600′ into its second ordepressed position 600B′. In some embodiments, this is a result of theneedle encountering resistance and not being able to advance. Thiscauses the needle hub 130 to be decoupled from the stylet hub 430,allowing the stylet hub 430 to advance relative to the needle hub 130.As the trigger is actuated further, the stylet hub 430 advances furtherrelative to the needle hub 130, as shown previously in FIGS. 6u and 6vand is further illustrated in FIGS. 6v (i), and 6 v(ii). In oneparticular embodiment, the stylet hub 430 is advanced to allow thestylet to engage the suture holder at the distal tip to allow the sutureholder to be retracted with the stylet. As the trigger is then releasedthe stylet hub 430 and the needle 130 retract together as a unit. Theneedle release button 600′ remains in its depressed position 600B′ andhook 604′ of the needle release button 600′ rides above the tab 1408 asshown in FIG. 6w and further illustrated in FIGS. 6w (i) and 6 w(ii).When the trigger is fully released, the stylet hub 430 and needle hub130 have been retracted proximally as shown in FIG. 6x , and the styletwithdraws the suture holder proximally as it is retracted. The needlerelease button 600′ remains in its depressed or second position 600B′.

In some of the embodiments described above with respect to FIGS. 6m-6x ,the springs illustrated in the figures are shown in their uncompressedstate but as would be known to one skilled in the art the springs willbe compressed between the respective components.

Alternative Embodiment for Passing Suture to Distal Tip and Capturingthe Suture Using the Suture Trap

In accordance with an alternative embodiment of the present invention, amethod is disclosed for passing suture, the method comprising passingsuture from the device proximal portion to the distal tip to be heldtherein, and capturing the suture using the suture holder whileretrieving the suture holder from the distal tip. In operation, thedevice 100 is positioned within a region of tissue having a defect. Thedevice is positioned such that a first segment of tissue is positionedwithin a tissue receiving gap 10 of the device 100. The suture 240 maybe held within a needle 116 for example within a notch 117 as shown inFIG. 20B, and the needle 116 may then be advanced to pass the suture 240through the first segment of tissue. A stylet 319 may additionally behoused within the needle and may be used in conjunction with the needle116 to slide the suture 240 into the trap 2016. In one example, thestylet 319 may be advanced distally further than the needle 116 to passthe suture 240 through both slot 2040 a of the distal tip 12 and slot2042 a of the trap 2016, as shown in dashed outline in FIG. 20C. Thestylet 319 may then be translated further such that it pushes the suture240 through the resilient tab 2040 c of the distal tip 12. The needle116 and the stylet 319 may then be retracted. The suture 240 is heldwithin slot 2040 b within the distal tip 12 and knot 250 rests againstan outer surface of the distal tip 12. The knot may be larger than theopening defined by slot 2040 b to help prevent the suture 240 fromdisengaging from the distal tip 12. The suture 240 is held between thetwo sets of tabs 2040 c and 2042 c as shown in FIG. 20C. Alternatively,the needle 116 may be sized to be received within the trap 2016 and maybe used to push the suture 240 through tabs 2040 c into slot 2040 b ofdistal tip 12, with the suture 240 being routed through a notch withinthe needle.

The device 100 may then be repositioned such that the second segment oftissue is received within the tissue receiving gap 10. The needle 116and a stylet 319 housed within the needle 116 may both be advancedthrough the second segment of tissue. The needle 116 may be translatedlongitudinally until it abuts against the trap 2016. The stylet 319 maythen advanced further through the trap 2016 such that it engages thetrap 2016. The suture 240 at this point is held between the two sets oftabs 2040 c and 2042 c. The suture 240 is positioned distal to tab 2040c and proximal to tab 2042 c. The stylet 319 is then retracted allowingthe trap 2016 to be pulled along with it. As the trap 2016 is retracted,the movement of the trap 2016 relative to the distal tip 12 causes thesuture 240 to pass through the second set of tabs 2042 c and into theslot 2042 b of the trap 2016. The stylet 319 and thus the 2016 isretracted further the suture 240 disengages or slips/squeezes throughthe first set of tabs 2040 c and moves into slot 2040 a. Thus suture 240is now held or captured within slot 2042 b of the trap 2016 and has beendisengaged from the distal tip 12, as shown in FIG. 20E. The stylet 319,trap 2016 and thus suture 240 are then withdrawn further through thesecond segment of tissue. Thus, the suture 340 has been passed throughboth the first and second segment of tissue around the defect. Thedefect may be approximated by deploying a knot to tighten and tie thetwo ends of the suture. In other embodiments, slot 2040 of the devicedistal tip may not comprise a pair of tabs 2040 c. In one suchembodiment the suture 240 is passed from the device proximal portion tothe distal tip 12 through the first segment of tissue as describedpreviously. The suture 240 is coupled to the distal tip 12 by passingsuture 240 through the pair of tabs 2042 c of the trap 2016 using thestylet 319, wherein trap 2016 is coupled to the distal tip 12. The trap2016 can then be disengaged from the distal tip 12 and retracted usingthe stylet 319 to pass suture 240 through the second segment of tissueas previously described.

The embodiments of the invention described above are intended to beexemplary only. The scope of the invention is therefore intended to belimited solely by the scope of the appended claims.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the broad scope of theappended claims. All publications, patents and patent applicationsmentioned in this specification are herein incorporated in theirentirety by reference into the specification, to the same extent as ifeach individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

We claim:
 1. A bi-directional suture passer, comprising: a proximalportion for holding a portion of a suture therein, a distal tip coupledto the proximal portion and defining a tissue receiving gapthere-between; a reciprocally moveable suture passing member housedwithin the proximal portion for translating the suture portion betweenthe proximal portion and the distal tip; and a suture holder operable tobe detachably coupled to the distal tip for releasably retaining thesuture portion passed by the suture passing member; the suture holdercomprising a suture retaining component for releasably retaining thesuture portion passed by the suture passing member and a memberengagement feature for coupling to the suture passing member; the suturepassing member having a first orientation relative to the suture holderfor depositing the suture portion into the suture holder to be retainedby the suture retaining component while allowing the suture passingmember to be retracted freely from the suture holder; the suture passingmember having a second, engaging orientation relative to the sutureholder wherein the suture passing member is configured to engage withthe member engagement feature of the suture holder for retrieving thesuture holder from the distal tip; and the suture retaining componenthaving a first configuration in which the suture retaining componentflexes to allow the suture portion to pass at least partiallytherethrough, and a second configuration in which the suture retainingcomponent substantially prevents the suture portion from being retractedtherefrom.
 2. The suture passer of claim 1, wherein the suture holder isinitially positioned within the distal tip.
 3. The suture passer ofclaim 1, wherein the suture passing member comprises a suture passingmember engagement feature for engaging with the member engagementfeature of the suture holder.
 4. The suture passer of claim 1, whereinthe member engagement feature is configured to permit the suture passingmember in its second engaging orientation to pass beyond the memberengagement feature and to prevent the suture passing member from beingretracted therefrom.
 5. The suture passer of claim 1, further comprisinga tissue puncturing member housed within the proximal portion.
 6. Thesuture passer of claim 5, wherein the suture holder comprises a beveledproximal face configured to interact with a beveled distal face of thetissue puncturing member.
 7. The suture passer of claim 1, wherein thesuture retaining component comprises a tapered spring pin that opens, inthe first configuration, to allow passage of a suture portiontherethrough and subsequently closes, in the second configuration, uponpassage of the suture portion, whereby the suture portion is retained bya distal end of the suture holder.
 8. The suture passer of claim 1,wherein the suture retaining component comprises one or more resilientmembers.
 9. The suture passer of claim 8, wherein the one or moreresilient members project from a surface of the suture holder forrestraining motion of a portion of a suture passed beyond the one ormore resilient members.
 10. The suture passer of claim 9, wherein theone or more resilient members are inwardly biased with respect to thesuture holder.
 11. The suture passer of claim 10, wherein the one ormore resilient members comprises a plurality of resilient members. 12.The suture passer of claim 8, wherein the one or more resilient membersare located at a distal end of the suture holder.
 13. The suture passerof claim 1, wherein the suture retaining component is operable to retainthe portion of the suture that is passed therethrough on a side of atissue opposite a user.
 14. The suture passer of claim 1, wherein thesuture retaining component is the member engagement feature.
 15. Abi-directional suture passer, comprising: a proximal portion for holdinga portion of a suture therein, a distal tip coupled to the proximalportion and defining a tissue receiving gap there-between; areciprocally moveable suture passing member housed within the proximalportion for translating the suture portion between the proximal portionand the distal tip; and a suture holder operable to be detachablycoupled to the distal tip for releasably retaining the suture portionpassed by the suture passing member; the suture holder comprising asuture retaining component for retaining the suture portion passedbeyond the suture retaining component during a medical procedure and anengagement feature for releasably coupling to a portion of the suturepasser; the suture passing member having a first orientation relative tothe suture holder for depositing the suture portion into the sutureholder to be retained by the suture retaining component while allowingthe suture passing member to be retracted freely from the suture holder;and the suture passing member having a second engaging orientationrelative to the suture holder wherein the suture passing member definesa suture holder retrieving member that is configured to engage with thesuture holder for retrieving the suture holder from the distal tip; andthe suture retaining component having a first configuration in which thesuture retaining component flexes to allow the suture portion to pass atleast partially therethrough, and a second configuration in which thesuture retaining component substantially prevents the suture portionfrom being retracted therefrom.
 16. The suture passer of claim 15,wherein the engagement feature is selected from the group consisting ofa notch, a projection and a fin.
 17. The suture passer of claim 15, thesuture holder comprising a member engagement feature for coupling to thesuture holder retrieving member.
 18. The suture passer of claim 17,wherein the member engagement feature is configured to preventdecoupling of the suture holder from the suture holder retrievingmember.
 19. The suture passer of claim 18, wherein the member engagementfeature is configured to permit the suture holder retrieving member topass beyond the member engagement feature and to prevent the sutureholder retrieving member from being retracted therefrom.
 20. The suturepasser of claim 19, wherein the member engagement feature comprises oneor more resilient fingers.
 21. The suture passer of claim 17, whereinthe suture retaining component is the member engagement feature.
 22. Thesuture passer of claim 17, wherein the suture holder retrieving memberis an elongate member selected from the group consisting of a rod, aneedle and a stylet.
 23. The suture passer of claim 22, wherein thesuture holder retrieving member includes a recessed portion.
 24. Thesuture passer of claim 23, wherein the recessed portion comprises anundercut for engaging with the member engagement feature of the sutureholder.
 25. The suture passer of claim 23, wherein the member engagementfeature comprises one or more resilient fingers and wherein the recessedportion is configured to engage the one or more resilient fingers uponpassage of the suture holder retrieving member beyond the one or moreresilient fingers.
 26. The suture passer of claim 17, wherein the suturepassing member is rotatable to transition between the first and secondorientations.
 27. The suture passer of claim 15, wherein the suturepassing member is an elongate member selected from the group consistingof a rod, a needle and a stylet.
 28. The suture passer of claim 15,further comprising the suture portion being held within the proximalportion.
 29. The suture passer of claim 28, wherein the suture portionis selected from the group consisting of a metal tab, a plastic tab anda suture knot, and wherein the suture portion is coupled to a suturestrand.
 30. The suture passer of claim 15, further comprising a tissuepuncturing member housed within the proximal portion.
 31. The suturepasser of claim 30, the tissue puncturing member being reciprocallymoveable between the proximal portion and the distal tip for puncturinga segment of tissue received within the tissue receiving gap.
 32. Thesuture passer of claim 30, further comprising an actuating member forcausing reciprocal movement of the suture passing member and the tissuepuncturing member.
 33. A bi-directional suture passer, comprising: aproximal portion for holding a portion of a suture therein; a distal tipcoupled to the proximal portion and defini a tissue receiving gapthere-between; a reciprocally moveable suture passing member housedwithin the proximal portion for translating the suture portion betweenthe proximal portion and the distal tip; and a suture holder operable tobe detachably coupled to the distal tip for releasably retaining thesuture portion passed by the suture passing member; the suture holdercomprising a suture retaining component for releasably retaining thesuture portion passed by the suture passing member, the suture retainingcomponent comprising at least three resilient fingers; the suturepassing member having a first orientation relative to the suture holderfor depositing the suture portion into the suture holder to be retainedby the suture retaining component while allowing the suture passingmember to be retracted freely from the suture holder; the suture passingmember having a second engaging orientation relative to the sutureholder wherein the suture passing member is configured to engage withthe suture holder for retrieving the suture holder from the distal tip;and the suture retaining component having a first configuration in whichthe suture retaining component flexes to allow the suture portion topass at least partially therethrough, and a second configuration inwhich the suture retaining component substantially prevents the sutureportion from being retracted therefrom.
 34. A bi-directional suturepasser, comprising: a proximal portion for holding a portion of a suturetherein; a distal tip coupled to the proximal portion and defining atissue receiving gap there-between; a reciprocally moveable suturepassing member housed within the proximal portion for translating thesuture portion between the proximal portion and the distal tip; a sutureholder operable to be detachably coupled to the distal tip forreleasably retaining the suture portion passed by the suture passingmember; the suture holder comprising a suture retaining component forreleasably retaining the suture portion passed by the suture passingmember and the suture passing member comprising a suture passing memberengagement feature for releasably retaining the suture holder; thesuture passing member having a first orientation relative to the sutureholder for depositing the suture portion into the suture holder to beretained by the suture retaining component while allowing the suturepassing member to be retracted freely from the suture holder; and thesuture passing member having a second engaging orientation relative tothe suture holder wherein the suture passing member is configured toengage with the suture holder for retrieving the suture holder from thedistal tip; and the suture retaining component having a firstconfiguration in which the suture retaining component flexes to allowthe suture portion to pass at least partially therethrough, and a secondconfiguration in which the suture retaining component substantiallyprevents the suture portion from being retracted therefrom.
 35. A sutureholder for use with a suture passer having a suture passing member, thesuture holder comprising: a suture retaining component for retaining aportion of a suture passed beyond the suture retaining component duringa medical procedure; and an engagement feature for releasably couplingto a portion of the suture passer; wherein the suture retainingcomponent when used with a suture passing member in a first relativeorientation, retains the suture portion passed beyond it to be depositedthere through while allowing the suture passing member to be retractedfreely from the suture holder, and when used with the suture passingmember in a second relative orientation, allows for the suture holder tobe releasably retained by the suture passing member; and the sutureretaining component having a first configuration in which the sutureretaining component flexes to allow the suture portion to pass at leastpartially therethrough, and a second configuration in which the sutureretaining component substantially prevents the suture portion from beingretracted therefrom.